HFD100 recallZ-0934-2022 · Deerfield Imaging, Inc. · initiated Feb 17, 2022

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number

Z-0934-2022

Status

Terminated

Initiated by the company

Feb 17, 2022

Recalling firm

Deerfield Imaging, Inc.

Quantity

24

Product code

HBL

FDA submissions

K103493

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 description

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• HFD100 119629-000

  IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)
  1 recall6 reports
• HFD100 119630-000

  IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)
  1 recall0 reports

Product lines

• HFD100IMRIS Imaging, Inc. · 3 models · 7 reports · 2 recalls

Other devices under the same FDA submission

2 devices cleared under K103493 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Head Fixation Device HFD100

  IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)
  1 recall13 reports
• HFD100 119695-000

  IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)
  1 recall1 report