FDAClass IIAugust 8, 2018

Optima CT 520 recall

Optima CT 520

Why was Optima CT 520 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?

Serial number, CBCRG1700051HM, System ID Number 580622O520, UDI Number 01008406821025681117120021CBCRG1700051HM

Product
Optima CT 520
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