Recall Z-1965-2019— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-07-02, terminated 2020-10-05. It names 3 FDA 510(k) clearances: K181783, K180535, K180374. 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..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-02
- Terminated
- 2020-10-05
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K181783 — LOGIQ P9; LOGIQ P7
- K180535 — Voluson P6 and Voluson P8
- K180374 — Voluson S8/ Voluson S10/ Voluson S10 Expert
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.