FDAClass IIAugust 8, 2018

Revolution CT 160 1.5D STD WAUK recall

Revolution CT 160 1.5D STD WAUK

Why was Revolution CT 160 1.5D STD WAUK recalled?

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

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 Number 5590000-6. Serial number REVVX1800021CN (System ID 812842REV, UDI 01008406821185521118020021REVVX1800021CN), Serial Number REVVX1800004CN (System ID 269375REVOCT, UDI 01008406821185521118010021REVVX1800004CN).

Product
Revolution CT 160 1.5D STD WAUK
Recalling firm
GE Healthcare, LLC
Quantity
42 units total
Distribution
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
Recall date
August 8, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls