FDAClass IIJuly 24, 2019

Refurbish RIC5-9-D Probe ROHS compliant Ultrasound recall

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

Why was Refurbish RIC5-9-D Probe ROHS compliant Ultrasound recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Recalling firm
GE Healthcare, LLC
Quantity
3 devices
Distribution
Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Recall date
July 24, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls