Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2301-2025·Announced 2025-08-20

Discovery MR450 1.5T scanners recalled over patient table caster lock maintenance

GE HealthCare is recalling 19 Discovery MR450 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

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 2/5 (Moderate).

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: Rubric level 2 covers voluntary precautionary actions; the notice reports an unconfirmed maintenance step rather than a device defect, and no injuries.

Plain-English summary

GE HealthCare is recalling the Discovery MR450 1.5T nuclear magnetic resonance imaging system. The recall covers 19 units distributed worldwide, identified by the system ID numbers on which GE HealthCare performed planned maintenance during the covered period.

GE HealthCare became aware that, for a group of MR systems that includes SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR and SIGNA Artist Evo, the planned maintenance steps that check the functionality of the caster locks on the MR patient table may not have been performed. The FDA classified the action as Class II.

Imaging sites operating an affected system should follow the manufacturer's instructions for having the caster lock check completed. GE HealthCare is contacting affected customers directly.

The recalled product

Product: GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — MRI System
Hazard: maintenance-verification
patient-table
caster-lock
class-ii
Affected units: 19

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 (3)

GTIN: Not available
Not applicable
2023

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 22 recalled by GE Medical Systems, 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 22 products in this recall →

Same manufacturer · GE Medical Systems, LLC

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