Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

Recall Insight

This FDA Devices action (record #Z-2412-2021) was formally reported on September 15, 2021, with the manufacturer initiating the action on August 11, 2021. It is classified under Moderate severity (Class II), with a current status of Completed. Philips North America Llc is listed as the recalling firm, operating out of Cambridge, MA. Federal records indicate 42 units units are affected.

The documented reason for this recall is: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria,…. 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 5 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.