RecallRadar

FDA Device recall Z-1395-2015

GE Discovery MR950 MRI system

On 2015-05-13 the FDA classified a Class II recall of GE Discovery MR950 MRI system by Ge Healthcare, citing the alignment lasers are missing the labels required by radiation safety regulations.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1395-2015
ClassificationClass II
Statusterminated
Initiated2014-10-24
Published2015-05-13
Last updated2026-09-13 11:53 UTC
CompanyGe Healthcare
DistributionCA

Product

GE Discovery MR950 MRI system

Reason

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

Identifiers

code_infoModel Number - Discovery MR950

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1395-2015%22

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