TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosu
FDA device recall Z-0364-2012 · posted 2011-12-02 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.
- Action taken
- On 11/04/2011, an Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps. Varian is developing a corrective action for this issue. A customer service representative will contact you when the correction is available to schedule installation on your system. Questions regarding the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- -IYE
- Distribution
- Worldwide distribution including the US and Internationally.
- Date initiated
- 2011-10-31
- Date posted
- 2011-12-02
- Date terminated
- 2012-07-25
- 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 |