Recalls / —

—#174510

Product

Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

FDA product code

IYN — System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K180374, K180535, K181783

Affected lot / code info

Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9.   Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)

Why it was recalled

Potential for a transducer mis-alignment in certain transvaginal probes.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

Timeline

Recall initiated

2019-07-02

Posted by FDA

2019-07-12

Terminated

2020-10-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #174510. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.