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.
Check against the official notice below — it lists the full affected range.
Deerfield Imaging, Inc. is recalling the Trumpf Mount Clamp Assembly (part #118704-000), a component of the IMRIS HFD100 head fixation device in models #119629-000 and #119630-000. The mount clamp may rotate and not return to its proper position after normal lateral forces are applied during use. To compensate for this deflection, users have tightened the hand knob screw so much that it becomes difficult to loosen later, and the rotational movement at the table attachment point could go unnoticed during medical procedures.
This undetected movement could lead to situations requiring additional surgical intervention, loss of surgical navigation requiring recalibration, extended time under anesthesia, or ergonomic injury to staff when attempting to remove the equipment. The recall affects 24 devices distributed worldwide, including nine U.S. states and Sweden and Switzerland, identified by specific model numbers, UDIs, and serial numbers. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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. Quantity: 24 Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.