Trumpf Mount Clamp Assembly — Class II medical device recall Z-0934-2022
Terminated recall by Deerfield Imaging, Inc., reported 2022-04-20, distributed nationwide. Reports have been received that after normal or routine lateral forces are applied to the head fixation device
| Recall number | Z-0934-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deerfield Imaging, Inc., Minnetonka, MN, United States |
| Recall initiated | 2022-02-17 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, SE |
| Quantity | 24 |
| UPC / GTIN / UDI-DI | 00857534006592, 00857534006615 |
| Serial numbers | 10007550, 10007555, 10007556, 10007557, 10007558, 10008158, 10008159, 10008160, 10008161, 10008164, 10008165, 10008859, 10008860, 10008861, 10008862, 10008863, 10008864, 10008865, 10010668, 10010669, 10010672, 10010673, 10010674, 10010675 |
| Model numbers | 118704-000, 119629-000, 119630-000 |
Product
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.
Reason for recall
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 distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0934-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.