DRX-Revolution Mobile X-Ray System recallZ-2651-2017 · Carestream Health Inc · initiated May 25, 2017
Class II Terminated All recalls posted in June 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carestream Health Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910.
Recall details
- Recall number
- Z-2651-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 25, 2017
- Posted by the FDA
- Jun 19, 2017
- Recalling firm
- Carestream Health Inc
- Quantity
- Domestic: 1449 units; Foreign: 1416 units
- Product code
- IZL
- FDA submissions
- K120062
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.
Product description
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Code information (models, lots, serial numbers)
Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482
Other devices under the same FDA submission
1 device cleared under K120062 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · System, x-ray, mobile2 recalls12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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