PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 21, 2015 Initiated: December 19, 2014 #Z-0985-2015

Product Description

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

Reason for Recall

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

Details

Recalling Firm
GE Healthcare
Units Affected
13 (7 US, 6 OUS)
Distribution
US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.. Recalled by GE Healthcare. Units affected: 13 (7 US, 6 OUS).
Why was this product recalled?
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0985-2015.