Recall Z-0934-2022 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Deerfield Imaging, Inc.
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.
| Date | Feb 17, 2022 |
| Status | Terminated |
| Reason | 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 surg |
| 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) Ensu |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103493 | HEAD FIATION DEVICE (HFD 100) Imris, Inc., Mar 11, 2011 |