Recall Z-1964-2019— 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 5 FDA 510(k) clearances: K181985, K173555, K170445 and 2 more. Product: Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D. 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
5 on FDA's record- K181985 — Voluson E6, Voluson E8, Voluson E10
- K173555 — LOGIQ E10
- K170445 — LOGIQ S8
- K160182 — LOGIQ S7 Expert
- K152309 — LOGIQ E9, LOGIQ E9 XDClear 2.0
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.