FDAClass IIAugust 8, 2018

Discovery MI Digital Ready recall

Discovery MI Digital Ready

Why was Discovery MI Digital Ready recalled?

DIGITAL ReadyCT/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 5986030. a. Serial Number PTDMI1800003PT, System ID Number RADNETPT1839, UDI Number 01008406821209751118010421PTDMI1800003PT; b. Serial Number PTDMI1800005PT, System ID Number RADNETPT1838, UDI Number 01008406821209751118010421PTDMI1800003PT; c. Serial Number PTDMI1800009PT, System ID Number 813745DMIDR2, UDI Number 01008406821209751118021921PTDMI1800009PT

Product
Discovery MI Digital Ready
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