Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
FDA device recall Z-2181-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.
- Action taken
- Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 20
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-04-05
- Date posted
- 2011-05-10
- Date terminated
- 2012-06-19
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY MX (K092871) | Varian Medical Systems, Inc. | 2009-11-30 |