Recall record at a glance
| Official record | Z-0491-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Carestream Health Inc. |
| Report date | Jan 15, 2014 |
| Recall initiation date | Aug 29, 2013 |
| Quantity | 310 systerms domestically |
| Location | Rochester, NY, United States |
Official product description
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.
Why the product was recalled
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 information
Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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