GE Healthcare, LLC recalls Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
- Recall date
- July 2, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1965-2019
- FDA classification
- Class II
- Brand / firm
- GE Healthcare, LLC
- Sold / distributed
- Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Why it was recalled
Potential for a transducer mis-alignment in certain transvaginal probes.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
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