Repair RIC5-9A-RS System — Class II medical device recall Z-1965-2019
Terminated recall by GE Healthcare, LLC, reported 2019-07-24, distributed in TX. Potential for a transducer mis-alignment in certain transvaginal probes.
| Recall number | Z-1965-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-07-02 |
| Classified | 2019-07-12 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-10-05 |
| Distributed | TX |
| Countries outside the US | CH, FR, GR |
| Quantity | 2 devices |
| Serial numbers | 152323KR2, 205375KR9 |
| Model numbers | H48701EJ, KTZ157043-R |
Product
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Reason for recall
Potential for a transducer mis-alignment in certain transvaginal probes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1965-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.