Recall Z-1965-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
| 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 | 2 devices |
| Distribution | Distribution in the US to Texas. International distribution to France, Greece and Switzerland. |
| FDA record | Open on fda.gov |