GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-1965-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 2, 2019

Date Posted: July 24, 2019

Recall Number: Z-1965-2019

Event ID: 83271

Reason for Recall:

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

Status: Terminated

Product Quantity: 2 devices

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated