GE Healthcare Vivid S60N, ultrasound device
FDA Recall Z-2126-2023 · Posted 2023-07-10
Recalling FirmGE Vingmed Ultrasound As
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2023-05-30
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.
Firm Action
GE 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.
Root Cause
Process design
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics · 2023-02-16K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022-07-15K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2021-06-09K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020-07-16K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018-10-19K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017-06-14
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.