Skip to content
Recall Observatory FDA recall evidence

Device product

GE Healthcare Vivid S60N, ultrasound device

Z-2126-2023

May 30, 2023

Class II

Product summary

Firm
GE Vingmed Ultrasound As
Event
Event 92505
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2126-2023

Official wording

Reason: 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.

Code information: Software versions: v203, v204, v205, v206

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.