Reported Aug 29, 2012 · Terminated
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic…
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 Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
- Lot codes and dates
- Serial numbers
175 of 175 codes
2791PU22797PU92817PU52824PU12827PU42899PU32900PU92901PU72918PU12919PU92922PU32939PU73095PU73103PU93107PU03219PU33223PU53224PU33230PU03233PU43236PU73358PU93368PU83500PU63513PU93514PU63516PU23523PU83562PU63580PU83957PU83973PU53978PU43994PU14012PU14018PU84025PU34029PU54041PU04043PU64378PU64394PU34397PU64446PU14458PU64767PU04777PU94782PU94787PU84793PU64795PU14797PU74799PU34800PU94803PU34806PU64812PU44813PU24815PU74818PU1
- Serial numbers
- Amount recalled
- 175 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
X-ray units did not meet manufacturer's specification for linearity.
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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