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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare

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  Class 2 Device Recall GE Healthcare see related information
Date Initiated by Firm September 08, 2023
Date Posted October 23, 2023
Recall Status1 Open3, Classified
Recall Number Z-0143-2024
Recall Event ID 93053
510(K)Number K211312  
Product Classification System, image processing, radiological - Product Code LLZ
Product Universal Viewer Workflow Manager, Image processing radiological system
Code Information UDI/DI 00195278379610, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted.
Recalling Firm/
Manufacturer		 GE Healthcare
500 W Monroe St
Chicago IL 60661-3671
For Additional Information Contact GE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		 When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
FDA Determined
Cause 2		 Software design
Action GE Healthcare notified consignees on about 09/08/2023 via letter. Consignees were instructed that until the software update is available the device can still be utilized through an updated browser setting or through discontinuing the use of bi-directional reporting. A GE Healthcare representative will contact each consignee to arrange for the correction. Consignees were instructed to complete and return the provided acknowledgement response.
Quantity in Commerce 57 units
Distribution Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = GE Healthcare
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