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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus XR/a

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 Class 2 Device Recall Proteus XR/asee related information
Date Initiated by FirmAugust 09, 2019
Date PostedSeptember 20, 2019
Recall Status1 Open3, Classified
Recall NumberZ-2449-2019
Recall Event ID 83647
510(K)NumberK993090 
Product Classification System, x-ray, stationary - Product Code KPR
ProductProteus XR/a (SlOK : K993090)
Code Information console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
FDA Determined
Cause 2		Device Design
ActionGE 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. A GE Healthcare representative will contact you to arrange for the correction . If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1- 800-437-1171or your local Service Representative.
Quantity in Commerce647 US; 167 OUS
DistributionWorldwide - US Nationwide
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 = KPR
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