Carestream DRX Evolution System, X-Ray System recallZ-1877-2013 · Carestream Health Inc. · initiated Jun 3, 2013

Class II Terminated All recalls posted in August 2013

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

Due to potential for an x-ray exposure technique change.

FDA root cause category: Radiation Control for Health and Safety Act

What the company is doing

Carestream will make the correction which includes the installation of a SW patch to the affected customer sites, and to any other affected customer sites utilizing the DRX Evolution with V5. 5 SW outside of the US. --- Once receiving FDA approval on the corrective action plan, the correction will be implemented to all affected devices at identified customer sites: 1. A notification letter was sent to all customers identifying the issue and highlighting the approved procedures of the Corrective Action Plan. The letters were sent on 8/16/13 via Certified Mail, Return Receipt Requested. 2. Carestream Health will contact the customer to schedule a service visit to install software updates to correct this issue. The installation time will be approximately one hour. 3. As stated in the customer notification letter, this software update will be provided to the customer at no expense. 4. All software updates are estimated to be completed within 1-3 months. 5. Carestream Health will provide monthly progress reports on the effectiveness of the plan, including the number of units corrected. Further questions please call (800) 328-2910.

Recall details

Recall number: Z-1877-2013
Recall class: Class II
Status: Terminated
Initiated by the company: Jun 3, 2013
Posted by the FDA: Aug 12, 2013
Recalling firm: Carestream Health Inc.
Quantity: US: 49 units; Foreign: 183 units (revised)
Product code: KPR
FDA submissions: K091889
Distribution: Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

Product description

Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Code information (models, lots, serial numbers)

Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software

Other devices under the same FDA submission

1 device cleared under K091889 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

CARESTREAM DRX-EVOLUTION Plus
Carestream Health, Inc. · System, x-ray, stationary
1 report

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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