FDA Device recall Z-0934-2022
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #1196…
- FDA Device
- Class II
- terminated
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #1196… by Deerfield Imaging, citing 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) an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0934-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-17 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deerfield Imaging |
| Distribution | US |
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
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.
Identifiers
| code_info | Model #119629-000, UDI 00857534006592; and model #119630-000, UDI 00857534006615. Serial numbers: 10008164, 10007550,…Model #119629-000, UDI 00857534006592; and model #119630-000, UDI 00857534006615. Serial numbers: 10008164, 10007550, 10007555, 10008864, 10008160, 10008161, 10008859, 10008860, 10010668, 10010669, 10010673, 10010674, 10010672, 10007556, 10007557, 10008862, 10008861, 10008158, 10008159, 10008863, 10008165, 10007558, 10008865, and 10010675. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Deerfield Imaging
- Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiograp…
FDA Device · Class II · 2020-01-08 · Deerfield Imaging - IMRIS MR/X-ray head fixation device, Model HFD200
FDA Device · Class II · 2019-10-30 · Deerfield Imaging
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0934-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.