FDA Device recall Z-1965-2019
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
- FDA Device
- Class II
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class II recall of Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D by Ge Healthcare, citing potential for a transducer mis-alignment in certain transvaginal probes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1965-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-02 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | TX |
Product
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Reason
Potential for a transducer mis-alignment in certain transvaginal probes.
Identifiers
| code_info | Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Ser…Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1965-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.