Food, drugs, devices › Carestream Health Inc.
Device recall: Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester,
Carestream Health Inc. (Rochester, NY) initiated this device recall on 29 Aug 2013; FDA lists 1 product record under event 66744, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 18 Nov 2015. Initiation: voluntary: firm initiated. Carestream Health Inc. has 30 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Carestream Health Inc., Rochester, NY.
Reason for recall
"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."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 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… | 310 systerms domestically | Class II | Terminated | 15 Jan 2014 |
Context
Other enforcement events for Carestream Health Inc.
All 30 events for Carestream Health Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Nov 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.