Reported Jan 29, 2014 · Terminated
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an…
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. · 1049 Ridge Rd W · Rochester, NY · 14615-2731
Is this the product you have?
- DR 7500 with FF WS These products are permanently installed diagnostic x-ray
- systems composed of 4 main componentsan operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions
- Lot codes and dates
- Catalog Numbers
8551046879134513334838649253886460511551181295088166670018451221671841824560785316758966780
- Service Code8087
- Catalog Numbers
- Amount recalled
- 493 units Total (107 units domestically & 386 units internationally)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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