The Recall Desk
ModerateFDA (Devices)·Z-1395-2015·Announced 2015-05-13

GE Discovery MR950 MRI Systems Recalled for Missing Laser Labels

GE Healthcare is recalling five Discovery MR950 MRI systems because alignment lasers lack required radiation safety labels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a missing label rather than a functional defect causing injury, fitting the criteria for minor labeling errors or low-risk issues.

Plain-English summary

GE Healthcare is recalling five units of the Discovery MR950 MRI system. The recall was initiated because the alignment lasers on these systems are missing the labels required by radiation safety regulations.

The affected units were distributed to the state of California in the United States, as well as internationally to Italy and Japan. The recall number for this action is Z-1395-2015.

Consumers and healthcare facilities with these specific MRI systems should contact GE Healthcare for instructions on how to resolve the labeling issue.

The recalled product

Product
GE Discovery MR950 MRI system
Manufacturer
GE Healthcare

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 (1)

  • Model Number - Discovery MR950

Distribution

Distributed in 1 state: