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Open, Classified

GE Healthcare Vivid S70, ultrasound device

FDA Recall Z-2125-2023 · Posted 2023-07-10

Recalling FirmGE Vingmed Ultrasound As
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2023-05-30
Product Quantity14 units

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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