Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 10, 2018
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with ga…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Varian Medical Systems recalled TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery Sys… - a moderate-severity action.
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery Sys… was recalled by Varian Medical Systems in October 10, 2018. Reason: Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory …. Check the official notice for the remedy. Verify recall #Z-0004-2019 with the FDA Devices before acting.
The recall
Varian Medical Systems issued this moderate-severity FDA Devices recall-Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory ….
- Moderate
- severity level
- 387 units
- affected scope
- Class II
- classification
- October 10, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0004-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0004-2019) was formally reported on October 10, 2018, with the manufacturer initiating the action on August 20, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Varian Medical Systems is listed as the recalling firm, operating out of Palo Alto, CA. Federal records list the affected scope as 387.
The documented reason for this recall is: Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system. Distribution data in the federal record shows the product reached: Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of : Algeria, Australia, Az…. 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 - 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 - 40,422 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
387
Related Recalls
6
0 from same agency
Product description
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Reason for recall
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0004-2019 |
| Date reported | October 10, 2018 |
| Date initiated | August 20, 2018 |
| Recalling firm | Varian Medical Systems |
| Firm location | Palo Alto, CA |
| Affected scope | 387 |
| Distribution | Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of : Algeria, Australia, Azerbaijan, Belgium, B… |
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-0004-2019) 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? ▼
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.. Recalled by Varian Medical Systems. Units affected: 387.
Why was this product recalled? ▼
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-0004-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of : Algeria, Australia, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, India, Ireland, Israel, Italy, Japan, Kazakhstan, Lebanon, Morocco, Nepal, The Netherlands, New Zealand, Norway, Panama, Poland, Reunion Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0004-2019) 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 10, 2018. 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.