LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.
FDA device recall Z-0978-2007 · posted 2007-06-28 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.
- Action taken
- The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 80 devices
- Distribution
- The medical devices were distributed to medical centers nationwide and worldwide.
- Date initiated
- 2007-03-09
- Date posted
- 2007-06-28
- Date terminated
- 2012-02-28
- Location
- Palo Alto, CA
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