Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 20, 2016
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Varian Medical Systems, Inc. recalled Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; … - a moderate-severity action.
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; … was recalled by Varian Medical Systems, Inc. in July 20, 2016. Reason: Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, s…. Check the official notice for the remedy. Verify recall #Z-2150-2016 with the FDA Devices before acting.
The recall
Varian Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, s….
- Moderate
- severity level
- Class II
- classification
- July 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2150-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2150-2016) was formally reported on July 20, 2016, with the manufacturer initiating the action on June 23, 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 21 AlignRT Plus in US, 1 International..
The documented reason for this recall is: Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different … Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.. 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
21 AlignRT Plus in US, 1 International.
Related Recalls
6
3 from same agency
Product description
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
Reason for recall
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2150-2016 |
| Date reported | July 20, 2016 |
| Date initiated | June 23, 2016 |
| Recalling firm | Varian Medical Systems, Inc. |
| Firm location | Palo Alto, CA |
| Affected scope | 21 AlignRT Plus in US, 1 International. |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom. |
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-2150-2016) 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? ▼
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.. Recalled by Varian Medical Systems, Inc.. Units affected: 21 AlignRT Plus in US, 1 International..
Why was this product recalled? ▼
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2016. Severity: Moderate. Recall number: Z-2150-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2150-2016) 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 July 20, 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.