Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 19, 2016
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no repo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Varian Medical Systems, Inc. recalled Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN… - a moderate-severity action.
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN… was recalled by Varian Medical Systems, Inc. in October 19, 2016. Reason: Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when …. Check the official notice for the remedy. Verify recall #Z-0077-2017 with the FDA Devices before acting.
The recall
Varian Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when ….
- Moderate
- severity level
- 75 units
- affected scope
- Class II
- classification
- October 19, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0077-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0077-2017) was formally reported on October 19, 2016, with the manufacturer initiating the action on September 13, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Varian Medical Systems, Inc. is listed as the recalling firm, operating out of Palo Alto, CA. Federal records list the affected scope as 75 devices.
The documented reason for this recall is: Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue Distribution data in the federal record shows the product reached: US Distribution and Internationally to 1 site in Canada, India and Morocco. 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
75 devices
Related Recalls
6
3 from same agency
Product description
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Reason for recall
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0077-2017 |
| Date reported | October 19, 2016 |
| Date initiated | September 13, 2016 |
| Recalling firm | Varian Medical Systems, Inc. |
| Firm location | Palo Alto, CA |
| Affected scope | 75 devices |
| Distribution | US Distribution and Internationally to 1 site in Canada, India and Morocco |
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-0077-2017) 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? ▼
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.. Recalled by Varian Medical Systems, Inc.. Units affected: 75 devices.
Why was this product recalled? ▼
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0077-2017.
Where was the recalled product distributed? ▼
Distribution: US Distribution and Internationally to 1 site in Canada, India and Morocco.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0077-2017) 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 October 19, 2016. 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.