Reported Apr 20, 2022 · Terminated
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation…
Deerfield Imaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Deerfield Imaging, Inc. · 5101 Shady Oak Rd S · Minnetonka, MN · 55343-4100
Is this the product you have?
- 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.
- Lot codes and dates
Model #119629-000UDI 00857534006592and model #119630-000UDI 00857534006615
- Serial numbers
1000816410007550100075551000886410008160100081611000885910008860100106681001066910010673100106741001067210007556100075571000886210008861100081581000815910008863100081651000755810008865and 10010675
- Amount recalled
- 24
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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