GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.

Recall Insight

This FDA Devices action (record #Z-0601-2022) was formally reported on February 16, 2022, with the manufacturer initiating the action on December 23, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. GE Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records indicate 17,228 devices total in this field correction units are affected.

The documented reason for this recall is: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Distribution data in the federal record shows the product reached: Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia, Australia, Austria…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.