FDAClass IIJanuary 21, 2015

GE Healthcare Revolution CT recall

GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

Why was GE Healthcare Revolution CT recalled?

Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

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?

Mfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3

Product
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Recalling firm
GE Healthcare
Quantity
13 (7 US, 6 OUS)
Distribution
US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
Recall date
January 21, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls