Product Safety Recalls

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GE Healthcare, LLC Recall 88150

Description: Revolution CT

GE Healthcare, LLC Recall 88150 Information

Mandated?FDA Mandated
Recall NumberZ-2004-2021
Event ID88150
Event DescriptionRevolution CT
Product TypeDevices
DistributionWorldwide distribution - US Nationwide
Quantity197 (US = 40; OUS = 157)
Recall ReasonGE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Device Classification20210714
Device Code Info5590000 5590000-6 5590000-2
Center Classification Date20210708
Recall Initiation Date20210319
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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