RecallDepth

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Company
Ge Healthcare, Llc
Recall Initiated
January 19, 2019
Recall Number
Z-1951-2019
Quantity
857 (US = 195: OUS = 662)
Firm Location
Waukesha, WI

Reason for Recall

Additional low dose radiation exposure.

Distribution

Worldwide - US Nationwide Distribution

Lot / Code Info

Revolution CT

Root Cause

Device Design

Action Taken

GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

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