Z-0934-2022Class II

Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head...

Name: Z-0934-2022 Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head...
Creator: Deerfield Imaging, Inc.
Published: 2022-02-17
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2022-02-17 / Terminated / root cause: design

FDA source

Deerfield Imaging, Inc. began a recall of Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and... on 2022-02-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0934-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-17
Posted: 2022-04-14
Terminated: 2024-05-15
Recalling firm: IMRIS Imaging, Inc.
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.
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
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.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued letters dated 2/17/2022 to its consignees via FedEx and email. The consignee was informed of the issue and that the firm is taking corrective actions to minimize the potential risk of injury, and informed they have been identified as having one or more of the affected mount clamp components that requires replacement. Until the HFD100 mount clamp component is replaced, the firm recommends preventive actions be taken that include: (1) Ensure the instructions in the Operator Manual for proper HFD100 linkage assembly are followed to produce rigid fixation; and (2) Ensure there is no movement of the mount clamp component and of the HFD100 linkages prior to clinical use. The consignee is requested to confirm the details provided on the last page of the letter and return the response to the recalling firm. The details to be confirmed are whether the facility still has the HFD mount clamp component at their facility and requests the serial number and whether it is currently in use.
Quantity in commerce: 24
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0934-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0934-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code HBL

K103493Class IIHead Fiation Device (Hfd 100)Imris, Inc. / cleared 2011-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)