Repair RIC5-9A-RS System recall
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Why was Repair RIC5-9A-RS System 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 H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)
- Product
- Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 2 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)