CLASS II Device recall · Reported 13 May 2015 · FDA Enforcement Report

GE Discovery MR950 MRI system recalled by GE Healthcare

GE Healthcare is recalling GE Discovery MR950 MRI system, distributed in California. The recall was initiated on 24 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number - Discovery MR950

Quantity recalled5 units (2 in US)

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-1395-2015
FDA event ID: 70701
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 24 Oct 2014
FDA classified: 1 May 2015
Reported: 13 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

24 Oct 2014	Recall initiated by company
1 May 2015	Classified by FDA	+189 days
13 May 2015	Published in enforcement report	+12 days

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

Reason for recall

The alignment lasers are missing the labels required by radiation safety regulations.

Product as listed by the FDA

GE Discovery MR950 MRI system

Where it was distributed

US Distribution to the state of CA., and Internationally to Italy and Japan.

California

Questions about this recall

Why was it recalled?

The alignment lasers are missing the labels required by radiation safety regulations.

Which lots are affected?

Model Number - Discovery MR950

Where was it sold?

US Distribution to the state of CA., and Internationally to Italy and Japan.

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

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