Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation d
Summary
The FDA issued a Class II for Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a compo by Deerfield Imaging, Inc.. 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 (rot.
Details
Source
Device Recall
External ID
Z-0934-2022
Action Date
2022-04-20
Status
Terminated
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 24
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-17
Company
Minnetonka, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Deerfield Imaging, Inc. has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Deerfield Imaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Deerfield Imaging, Inc. have FDA actions?
Deerfield Imaging, Inc. has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0934-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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