Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

Recall Insight

This FDA Devices action (record #Z-0934-2022) was formally reported on April 20, 2022, with the manufacturer initiating the action on February 17, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Deerfield Imaging, Inc. is listed as the recalling firm, operating out of Minnetonka, MN. Federal records indicate 24 units are affected.

The documented reason for this recall is: Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distan… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Switzerland.. 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.