Data Foundry

Medical device recalls 2019

Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D — Class II medical device recall Z-1964-2019

Terminated recall by GE Healthcare, LLC, reported 2019-07-24, distributed in TX. Potential for a transducer mis-alignment in certain transvaginal probes.

Recall numberZ-1964-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2019-07-02
Classified2019-07-12
Reported by FDA2019-07-24
Terminated2020-10-05
DistributedTX
Countries outside the USCH, FR, GR
Quantity3 devices
Serial numbers198026KR7, 205375KR9, 220616KR7, 226914KR0
Model numbersKTZ303987-R

Product

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

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-1964-2019. 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.