Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
FDA device recall Z-1965-2019 · posted 2019-07-12 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Potential for a transducer mis-alignment in certain transvaginal probes.
- Action taken
- 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 instructed to complete and return the Medical Device Notification Acknowledgement Response form. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 2 devices
- Distribution
- Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
- Date initiated
- 2019-07-02
- Date posted
- 2019-07-12
- Date terminated
- 2020-10-05
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOGIQ P9; LOGIQ P7 (K181783) | GE Healthcare | 2018-09-20 |
| Voluson P6 and Voluson P8 (K180535) | GE Healthcare | 2018-03-29 |
| Voluson S8/ Voluson S10/ Voluson S10 Expert (K180374) | GE Healthcare | 2018-03-13 |