Reported Aug 9, 2023 · Ongoing
OEC 9800 Systems with 9-inch Image Intensifier
GE OEC Medical Systems, 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: GE OEC Medical Systems, Inc · 384 N Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- OEC 9800 Systems with 9-inch Image Intensifier
- Lot codes and dates
- UDI-DI00840682114349
- Serial Numbers
89-031789-05548S-12938S-05098S-01088S-10298S-283689-30288S-157489-0609-RC89-13088S-039489-09798SXXXX036268SXXXX036838SXXXX036818S-18948S-01758S-298889-245989-210189-324589-162389-02968S-02008S-074889-159089-17138S-012489-02828S-258089-31328S-303989-345189-022389-11558SXXXX036808S-32788S-242689-29138S-116789-127889-18548S-0233-C8S-19268SXXXX0368289-21678S-11098SXXXX036798S-041089-1579-N89-192089-31028S-2046-C89-234089-046189-380989-3810
- Amount recalled
- 58
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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