Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 20, 2022
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.
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) an…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Deerfield Imaging, Inc. recalled Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of t… - a moderate-severity action.
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of t… was recalled by Deerfield Imaging, Inc. in April 20, 2022. Reason: Reports have been received that after normal or routine lateral forces are applied to the head fixation devic…. Check the official notice for the remedy. Verify recall #Z-0934-2022 with the FDA Devices before acting.
The recall
Deerfield Imaging, Inc. issued this moderate-severity FDA Devices recall-Reports have been received that after normal or routine lateral forces are applied to the head fixation devic….
- Moderate
- severity level
- 24 units
- affected scope
- Class II
- classification
- April 20, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0934-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0934-2022) was formally reported on April 20, 2022, with the manufacturer initiating the action on February 17, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Deerfield Imaging, Inc. is listed as the recalling firm, operating out of Minnetonka, MN. Federal records list the affected scope as 24.
The documented reason for this recall is: 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 distan… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
24
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0934-2022 |
| Date reported | April 20, 2022 |
| Date initiated | February 17, 2022 |
| Recalling firm | Deerfield Imaging, Inc. |
| Firm location | Minnetonka, MN |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0934-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Deerfield Imaging, Inc.. Units affected: 24.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0934-2022.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0934-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 20, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.