Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of… Recall
Issued April 20, 2022 · Deerfield Imaging, Inc.
In April 2022, Deerfield Imaging, Inc. recalled the Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Deerfield Imaging, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Deerfield Imaging, Inc.
- Category
- Health
- Recall date
- April 20, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Sw
- Recall number
- FDA-Z-0934-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Deerfield Imaging, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.