The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0140-2022·Announced 2021-10-27

MRI system software may produce incomplete 3D images

GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall of medical imaging device; missing MRI image slices could compromise diagnostic accuracy and clinical decision-making. No illnesses or injuries have been reported, placing this at Score 3 per the rubric for risk-of-harm products without reported harm.

Plain-English summary

The Optima MR450w 1.5T is a nuclear magnetic resonance imaging system manufactured by GE Healthcare. A software condition in version DV29.1 can cause some slices to be missing from 3D volume images, creating gaps in anatomical information.

Thirteen devices have been identified as affected. These have been distributed within the United States and internationally to countries including Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, the United Arab Emirates, and the United Kingdom.

Missing image slices can result in incomplete anatomical visualization in 3D images, potentially affecting diagnostic accuracy. The FDA has classified this as a Class II recall.

Facilities using affected equipment should contact GE Healthcare for instructions on available remediation options.

The recalled product

Product
Optima MR450w 1.5T nuclear magnetic resonance imaging system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
Affected units
13

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)

  • Software version DV29.1

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 10 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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