Skip to content
Recall Observatory FDA recall evidence

Device product

Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D

Z-1964-2019

July 02, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 83271
Status
Terminated
Classification
Class II
Quantity
3 devices
Official record key
device-enforcement:Z-1964-2019

Official wording

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

Code information: Model KTZ303987-R - Serial Number (UDI Number): 226914KR0 (01008406821084301118032721226914KR0), 198026KR7 (Not Available), 220616KR7 (01008406821084301117091521220616KR7), 205375KR9 (01008406821085531116071121205375KR9)

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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