The Recall Desk
HighFDA (Devices)·Z-2126-2023·Announced 2023-07-19

GE Healthcare Vivid S60N ultrasound devices experience boot-up delays

GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during 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 risk-of-harm product (emergency ultrasound device) where injury has not been reported. While classified as FDA Class II, no hospitalization or injury reports accompany it, placing it at High per the rubric's criteria for risk-of-harm products without reported harm.

Plain-English summary

GE Healthcare has identified an issue with certain Vivid S60N ultrasound systems manufactured by GE Vingmed Ultrasound As. The affected systems cannot boot up in a timely fashion, which can delay device availability during time-critical emergency situations.

The recall involves software versions v203, v204, v205, and v206 of the Vivid S60N. These devices have been distributed worldwide. The delayed boot time prevents the device from being ready for immediate use in emergency settings.

Healthcare facilities using affected systems should contact GE Healthcare or consult the FDA recall notice (Z-2126-2023) for guidance on corrective actions.

The recalled product

Product
GE Healthcare Vivid S60N, ultrasound device
Manufacturer
GE Vingmed Ultrasound As
Category
Medical Device — Ultrasound / Diagnostic Equipment
Hazard
  • device-startup-delay
  • emergency-access-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 (4)

  • Software versions: v203
  • v204
  • v205
  • v206

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category