Recalls / —
—#153981
Product
ONCOR" Avant-garde
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K031764
- Affected lot / code info
- Device Model# 1940035
Why it was recalled
Software update
Root cause (FDA determination)
Software design
Action the firm took
Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- Distributed throughout the United States
Timeline
- Recall initiated
- 2017-02-14
- Terminated
- 2017-12-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #153981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.