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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

GE Healthcare, LLC: Potential for a transducer mis-alignment in certain transvaginal probes.

Agency Publication Date: July 12, 2019
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Affected Products

Product: Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D

Model KTZ303987-R - Serial Number (UDI Number): 226914KR0 (01008406821084301118032721226914KR0), 198026KR7 (Not Available), 220616KR7 (01008406821084301117091521220616KR7), 205375KR9 (01008406821085531116071121205375KR9)

Product: Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83271
Status: Resolved
Manufacturer: GE Healthcare, LLC
Manufactured In: United States
Units Affected: 2 products (3 devices; 2 devices)
Agency Last Updated: September 25, 2020

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.