CLASS II Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

Trumpf Mount Clamp Assembly (table adapter component) recalled

Deerfield Imaging is recalling Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of, distributed nationwide in the US. The recall was initiated on 17 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #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.

Quantity recalled24

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0934-2022
FDA event ID: 89713
Recalling firm: Deerfield Imaging, Minnetonka, MN
Classification: Class II
Status: Terminated
Recall initiated: 17 Feb 2022
FDA classified: 14 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

17 Feb 2022	Recall initiated by company
14 Apr 2022	Classified by FDA	+56 days
20 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Florida Georgia Massachusetts Minnesota North Carolina New York Ohio Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Deerfield Imaging

All 21

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021Device	CLASS II	Operating room table recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	Nationwide
6 Oct 2021Device	CLASS II	Operating room table recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	Nationwide
6 Oct 2021Device	CLASS II	Operating room table recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	Nationwide
8 Jan 2020Device	CLASS II	iMRX MRI and Angiography System recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	CT, MA, VA
30 Oct 2019Device	CLASS II	Imris MR/X-ray head fixation device recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	FL, NH, TN

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