Recall Z-1964-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
| Date | Jul 12, 2019 (initiated Jul 2, 2019) |
| Status | Terminated |
| Reason | Potential for a transducer mis-alignment in certain transvaginal probes. |
| Root cause | Device Design |
| Action | GE Healthcare notified customers on about 07/02/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that they could continue to use the affected probes, but prior to performing a biopsy, customers should make sure they follow the instructions for safe use in the Basic User Manual to ensure proper device alignment, specifically including the biopsy, biopsy safety and biopsy setup sections. GE Healthcare will correct all affected devices at no cost and a GE Healthcare representative will contact customers to arrange for the correction. Customers were also instruc |
| Quantity | 3 devices |
| Distribution | Distribution in the US to Texas. International distribution to France, Greece and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 GE Medical Systems Ultrasound and Primary Care Diagnostics, Sep 14, 2015 |
| K160182 | LOGIQ S7 Expert GE Healthcare, Feb 26, 2016 |
| K170445 | LOGIQ S8 GE Healthcare, Apr 11, 2017 |
| K173555 | LOGIQ E10 GE Healthcare, Dec 20, 2017 |
| K181985 | Voluson E6, Voluson E8, Voluson E10 GE Healthcare, Nov 15, 2018 |