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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution Apex, Revolution CT

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 Class 2 Device Recall Revolution Apex, Revolution CTsee related information
Date Initiated by FirmJune 30, 2021
Date PostedApril 05, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0816-2022
Recall Event ID 89762
510(K)NumberK133705 K163213 K191777 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductRevolution CT, Revolution CT ES
Code Information Revolution CT, Revolution CT ES
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactHealthcare Service
800-437-1171
Manufacturer Reason
for Recall		The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionGE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.
Quantity in Commerce273 (51 US; 222 OUS) in total
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAK
510(K)s with Product Code = JAK
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