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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Vivid

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 Class 2 Device Recall GE Healthcare Vividsee related information
Date Initiated by FirmMay 30, 2023
Date PostedJuly 10, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2125-2023
Recall Event ID 92505
510(K)NumberK142323 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductGE Healthcare Vivid S70, ultrasound device
Code Information Software versions: V203, v204
Recalling Firm/
Manufacturer		 GE Vingmed Ultrasound As
Strandpromenaden 45
Horten Norway
For Additional Information ContactGE Healthcare Service
800-4371171
Manufacturer Reason
for Recall		GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
FDA Determined
Cause 2		Process design
ActionGE Healthcare sent an Urgent Medical Device Correction notice to its consignees on 05/30/2023 by mail (traceable means). The notice explained the problem with the instrument and provided the following: "You can continue to use your device. Please follow clinical practice guidelines, which include having a backup imaging plan when performing time-critical examinations or image-guided interventions." The devices will be corrected at no charge to the consignee.
Quantity in Commerce14 units
DistributionWorldwide 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 = IYN
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