Recall record at a glance
| Official record | Z-2651-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Carestream Health Inc. |
| Report date | Jul 5, 2017 |
| Recall initiation date | May 25, 2017 |
| Quantity | Domestic: 1449 units; Foreign: 1416 units |
| Location | Rochester, NY, United States |
Official 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
Why the product 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.
Distribution information
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.
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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