ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be
FDA device recall Z-1493-2012 · posted 2012-05-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).
- Action taken
- Siemens sent a Safety Advisory Notice with Update to all affected customers. The notice informed the customers of the risk of pressing the Motion Stop button repeatedly during treatment. Work Steps were provided for customers to follow.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IYE
- Distribution
- Worldwide Distribution - USA including the states of CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV
- Date initiated
- 2012-04-03
- Date posted
- 2012-05-07
- Date terminated
- 2012-07-25
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 160MLC OPTION (K092145) | Siemens Medical Solutions USA, Inc. | 2009-09-18 |
| MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC (K072486) | Hem Con Medical Technologies, Inc. | 2008-08-06 |