CLASS II ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report

GE Healthcare Vivid S70N, ultrasound device recalled

GE Vingmed Ultrasound As is recalling GE Healthcare Vivid S70N, ultrasound device. The recall was initiated on 30 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware versions: v203, v204, v205, v206

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2127-2023
FDA event ID: 92505
Recalling firm: GE Vingmed Ultrasound As, Horten, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 30 May 2023
FDA classified: 10 Jul 2023
Reported: 19 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

30 May 2023	Recall initiated by company
10 Jul 2023	Classified by FDA	+41 days
19 Jul 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

GE Healthcare Vivid S70N, ultrasound device

Where it was distributed

Worldwide distribution.

Questions about this recall

Is GE Healthcare Vivid S70N, ultrasound device recalled?

Yes. GE Vingmed Ultrasound As recalled GE Healthcare Vivid S70N, ultrasound device on 30 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2127-2023.

Why was it recalled?

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.

Which lots are affected?

Software versions: v203, v204, v205, v206

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Vingmed Ultrasound As

All 6

Reported	Class	Recall	Company	Reason	Where
17 Jul 2024Device	CLASS II	GE Vivid Ultrasound products recalled by GE Vingmed Ultrasound As	GE Vingmed Ultrasound As	Other	5 states
17 Jul 2024Device	CLASS II	GE Vivid Ultrasound products recalled by GE Vingmed Ultrasound As	GE Vingmed Ultrasound As	Other	5 states
19 Jul 2023Device	CLASS II	GE Healthcare Vivid S60, ultrasound device recalled	GE Vingmed Ultrasound As	Other	N/A
19 Jul 2023Device	CLASS II	GE Healthcare Vivid S70, ultrasound device recalled	GE Vingmed Ultrasound As	Other	N/A
19 Jul 2023Device	CLASS II	GE Healthcare Vivid S60N, ultrasound device recalled	GE Vingmed Ultrasound As	Other	N/A

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