Carestream Health recalls
Carestream Health appears in 86 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 86 |
|---|---|
| Published | 2012-08-22 to 2023-12-13 |
| By agency | FDA Device (86) |
| By classification | Class II (83), Class III (3) |
| By status | terminated (83), ongoing (3) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, US, UT, VA, VT, WA, WI, WV |
Recalls
- DRX Revolution Mobile X-Ray System
FDA Device · Class II · 2023-12-13 · Carestream Health
Reason: Unexpected failure of electrical components within the CPI generator. - The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consis…
FDA Device · Class II · 2023-11-15 · Carestream Health
Reason: There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained… - DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid…
FDA Device · Class II · 2023-03-08 · Carestream Health
Reason: After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result… - Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam…
FDA Device · Class II · 2020-01-22 · Carestream Health
Reason: Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. - OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) T…
FDA Device · Class II · 2019-05-01 · Carestream Health
Reason: When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam. - DRX-Revolution Mobile X-Ray System
FDA Device · Class II · 2017-07-05 · Carestream Health
Reason: Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly. - Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) --…
FDA Device · Class II · 2017-02-15 · Carestream Health
Reason: The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator. - Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid…
FDA Device · Class II · 2017-01-25 · Carestream Health
Reason: Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i… - Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Dia…
FDA Device · Class II · 2016-07-27 · Carestream Health
Reason: A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or dist… - CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490
FDA Device · Class II · 2016-05-11 · Carestream Health
Reason: Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)". - CARESTREAM Image Suite V4
FDA Device · Class II · 2016-05-11 · Carestream Health
Reason: Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)". - CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic…
FDA Device · Class II · 2015-09-02 · Carestream Health
Reason: Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph. - CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray im…
FDA Device · Class II · 2015-04-15 · Carestream Health
Reason: Units device head descended unexpectedly - CS 8100 3D, CATALOG # (s): 5311162, 5311188
FDA Device · Class II · 2015-04-15 · Carestream Health
Reason: Units device head descended unexpectedly - CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer
FDA Device · Class II · 2014-12-24 · Carestream Health
Reason: Reduced mammographic image quality when attempting to print true size multi-format images - DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- C…
FDA Device · Class II · 2014-12-24 · Carestream Health
Reason: While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that s… - Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system compo…
FDA Device · Class II · 2014-08-20 · Carestream Health
Reason: An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection… - KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installe…
FDA Device · Class II · 2014-08-13 · Carestream Health
Reason: A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times t… - INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc
FDA Device · Class III · 2014-08-13 · Carestream Health
Reason: The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitione… - Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc
FDA Device · Class III · 2014-08-13 · Carestream Health
Reason: The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitione… - Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc
FDA Device · Class II · 2014-03-12 · Carestream Health
Reason: Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. - Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608…
FDA Device · Class II · 2014-03-12 · Carestream Health
Reason: Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. - KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc
FDA Device · Class II · 2014-02-05 · Carestream Health
Reason: Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error. - Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for g…
FDA Device · Class II · 2014-02-05 · Carestream Health
Reason: Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allo… - DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator cons…
FDA Device · Class II · 2014-01-29 · Carestream Health
Reason: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. - DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator conso…
FDA Device · Class II · 2014-01-29 · Carestream Health
Reason: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. - DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, ov…
FDA Device · Class II · 2014-01-29 · Carestream Health
Reason: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. - Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The…
FDA Device · Class II · 2014-01-15 · Carestream Health
Reason: It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system. - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat… - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Reason: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer applicat…