The Recall Desk
HighFDA (Devices)·Z-2124-2023·Announced 2023-07-19

Ultrasound Device Boot Failure May Delay Emergency Availability

Certain GE HealthCare Vivid S60 ultrasound systems may not boot up in a timely fashion, potentially delaying device availability in time-critical emergency situations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses or injuries. The hazard is theoretical—potential delay in device availability in time-critical situations—without actual harm documented. Per the rubric, risk-of-harm products without reported injury are scored at 3.

Plain-English summary

GE HealthCare has identified that certain Vivid S60 ultrasound systems may not boot up in a timely fashion. The affected systems run software versions v203 or v204 and have been distributed worldwide, with 2 units identified as affected.

When boot-up failures occur, they can delay the availability of the device in time-critical emergency situations. Users with a Vivid S60 system should verify which software version their system is running and contact GE Vingmed Ultrasound As if they have the affected software versions v203 or v204.

The recalled product

Product
GE Healthcare Vivid S60, ultrasound device
Manufacturer
GE Vingmed Ultrasound As
Category
Medical Device — Ultrasound Equipment
Hazard
  • boot-failure
  • emergency-delay

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Software versions: v203
  • v204

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category