FDA Device recall Z-0491-2014

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
terminated
Published 2014-01-15

On 2014-01-15 the FDA classified a Class II recall of Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The… by Carestream Health, citing 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 i….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0491-2014
Classification	Class II
Status	terminated
Initiated	2013-08-29
Published	2014-01-15
Last updated	2026-09-13 11:53 UTC
Company	Carestream Health
Distribution	US

Product

Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

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.

Identifiers

code_info	DRX Revolution Mobile X-Ray Systems manufactured from June 2012 through October 2013: Serial Numbers DRXR00690, 111, 11… DRX Revolution Mobile X-Ray Systems manufactured from June 2012 through October 2013: Serial Numbers DRXR00690, 111, 114, 119, 121, 122, 123, 125, 126, 134, 142, 143, 151, 152, 153, 154, 155, 161, 162, 163, 164, 165, 166, 167, 168, 169, 173, 174, 176, 177, 178, 180, 181, 182, 183, 188, 189, 190, 191, 192, 196, 197, 198, 199, 201, 202, 203, 205, 206, 207, 208, 209, 211, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 254, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 275, 276, 279, 280, 281, 282, 283, 284, 285, 286, 305, 312, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 330, 331, 332, 333, 334, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 353, 355, 357, 358, 359, 360, 361, 362, 363, 364, 365, 372, 373, 375, 376, 379, 380, 381, 382, 383, 384, 385, 386, 388, 394, 395, 396, 397, 398, 399, 400, 401, 403, 405, 412, 413, 414, 415, 417, 420, 421, 423, 431, 432, 433, 434, 435, 441, 442

code_info

DRX Revolution Mobile X-Ray Systems manufactured from June 2012 through October 2013: Serial Numbers DRXR00690, 111, 11…

DRX Revolution Mobile X-Ray Systems manufactured from June 2012 through October 2013: Serial Numbers DRXR00690, 111, 114, 119, 121, 122, 123, 125, 126, 134, 142, 143, 151, 152, 153, 154, 155, 161, 162, 163, 164, 165, 166, 167, 168, 169, 173, 174, 176, 177, 178, 180, 181, 182, 183, 188, 189, 190, 191, 192, 196, 197, 198, 199, 201, 202, 203, 205, 206, 207, 208, 209, 211, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 254, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 275, 276, 279, 280, 281, 282, 283, 284, 285, 286, 305, 312, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 330, 331, 332, 333, 334, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 353, 355, 357, 358, 359, 360, 361, 362, 363, 364, 365, 372, 373, 375, 376, 379, 380, 381, 382, 383, 384, 385, 386, 388, 394, 395, 396, 397, 398, 399, 400, 401, 403, 405, 412, 413, 414, 415, 417, 420, 421, 423, 431, 432, 433, 434, 435, 441, 442

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Other recalls by Carestream Health

DRX Revolution Mobile X-Ray System
FDA Device · Class II · 2023-12-13 · Carestream Health
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
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
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
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

All Carestream Health recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0491-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.