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Deerfield Imaging, Inc. Recall: Trumpf Mount Clamp Assembly (table adapter component), par

Deerfield Imaging, Inc. Recall: Trumpf Mount Clamp Assembly (table adapter component), par is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Deerfield Imaging, Inc.; Product: Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fix

Recalling firmDeerfield Imaging, Inc.
ProductTrumpf 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.
Reason for recallReports 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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Switzerland.
Recall initiated20220217
Recall numberZ-0934-2022
Categorydevice
StateMN
CountryUnited States

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