Reported Jul 5, 2017 · Terminated
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China…
Carestream Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health Inc · 150 Verona St · Rochester, NY · 14608-1733
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
| — | DRX-Revolution Mobile X-Ray System |
DRXR-1 | — |
1060177 | Catalog # 1019397 (all other countries) and (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures |
- Lot codes and dates
- Serial NumbersWorldwide
- except China101 through 2623
- China only800101 through 800482
- Amount recalled
- Domestic: 1449 units; Foreign: 1416 units
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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