TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide ster
FDA device recall Z-1617-2012 · posted 2012-05-16 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of.
- Action taken
- An "Urgent Medical Device Correction / Field Safety Letter" was distributed to all affected users on April 9, 2012, with a description of the problem and user corrective action steps. The Letter was also distributed to the Varian Sales, Marketing, and Service organizations. Customers in the US and Canada may contact (888) 827-4265 for questions. *** An additional letter was sent on 11/5/12 to additional consignees identified by Varian as being affected the the recall but not previously notified.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 207 devices 12/7/12 - amended to 216 devices.
- Distribution
- Worldwide Distribution -- USA, and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Netherlands, New Zealand, Norway, Portugal, Russia,
- Date initiated
- 2012-04-09
- Date posted
- 2012-05-16
- Date terminated
- 2014-04-16
- Location
- Palo Alto, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUEBEAM (K111106) | Varian Medical Systems, Inc. | 2011-08-18 |