Ge Healthcare It recalls
Ge Healthcare It appears in 17 official U.S. recall notices indexed by RecallRadar, most recently on 2016-09-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 17 |
|---|---|
| Published | 2013-07-03 to 2016-09-14 |
| By agency | FDA Device (17) |
| By classification | Class II (16), Class III (1) |
| By status | terminated (17) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV, WY |
Recalls
- Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
FDA Device · Class II · 2016-09-14 · Ge Healthcare It
Reason: There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events… - Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the…
FDA Device · Class II · 2016-09-07 · Ge Healthcare It
Reason: The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Addit… - GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic an…
FDA Device · Class II · 2016-08-24 · Ge Healthcare It
Reason: While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are op… - Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be…
FDA Device · Class II · 2016-08-03 · Ge Healthcare It
Reason: A software defect was discovered that causes images to be out of context with clinical information. - Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
FDA Device · Class II · 2014-12-31 · Ge Healthcare It
Reason: GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full. - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class III · 2014-02-05 · Ge Healthcare It
Reason: GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal… - Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to…
FDA Device · Class II · 2014-01-22 · Ge Healthcare It
Reason: There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbn… - Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses…
FDA Device · Class II · 2014-01-22 · Ge Healthcare It
Reason: In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a me… - Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a p…
FDA Device · Class II · 2014-01-22 · Ge Healthcare It
Reason: There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a d… - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class II · 2014-01-08 · Ge Healthcare It
Reason: GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may uplo… - The GE Centricity Web
FDA Device · Class II · 2013-12-11 · Ge Healthcare It
Reason: GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for emb… - Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Lab…
FDA Device · Class II · 2013-11-27 · Ge Healthcare It
Reason: 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to rev… - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class II · 2013-11-27 · Ge Healthcare It
Reason: GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-ro… - The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare p…
FDA Device · Class II · 2013-11-06 · Ge Healthcare It
Reason: GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS… - Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from…
FDA Device · Class II · 2013-11-06 · Ge Healthcare It
Reason: Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intentio… - Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a sof…
FDA Device · Class II · 2013-10-30 · Ge Healthcare It
Reason: GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side b… - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class II · 2013-07-03 · Ge Healthcare It
Reason: If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages…