Reported Jul 24, 2019 · Terminated
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
GE Healthcare, LLC
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 Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
- Lot codes and dates
- Model KTZ303987-R -
- Serial Number (UDI Number)226914KR0 (01008406821084301118032721226914KR0), 198026KR7 (Not Available), 220616KR7 (01008406821084301117091521220616KR7), 205375KR9 (01008406821085531116071121205375KR9)
- Amount recalled
- 3 devices
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
Potential for a transducer mis-alignment in certain transvaginal probes.
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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