Product Safety Recalls

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GE Healthcare, LLC Recall 89027

Description: Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

GE Healthcare, LLC Recall 89027 Information

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-0242-2022
Event ID89027
Event DescriptionComputed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Product TypeDevices
DistributionWorldwide and US Nationwide Distribution
Quantity105 in total
Recall ReasonThe accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
Device Classification20211201
Device Code InfoRevolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Center Classification Date20211124
Recall Initiation Date20210630
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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