The Recall Desk
HighFDA (Devices)·Z-2127-2023·Announced 2023-07-19

GE Vivid S70N Ultrasound Device Boot Failure Recall

GE Healthcare recalls certain Vivid S70N ultrasound devices that may not boot promptly, potentially delaying availability in time-critical emergencies.

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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is potential rather than realized—startup delays could impact emergency device availability—but the risk remains theoretical without documented harm.

Plain-English summary

GE Vingmed Ultrasound As is recalling certain Vivid S70N ultrasound systems due to a software-related startup defect. The affected devices operate software versions 203, 204, 205, or 206.

These ultrasound systems are distributed worldwide. Certain units may fail to boot up in a timely fashion. When this occurs, it delays the device's availability in time-critical emergency situations.

The startup defect was identified by the manufacturer. The recall is classified as FDA Class II, indicating a potential health hazard.

The recalled product

Product
GE Healthcare Vivid S70N, ultrasound device
Manufacturer
GE Vingmed Ultrasound As
Category
Medical Device — Ultrasound / Diagnostic
Hazard
  • boot-failure
  • delayed-availability

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

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