ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy,
FDA device recall Z-0168-2016 · posted 2015-10-27 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option.
- Action taken
- Siemens sent Safety Advisory Notices, dated May 5th and 22nd, 2015 to all affected customers to inform them about an update of the Control Console software to correct defects affecting the Control Console with their digital Linear Accelerator. Customers were instructed to ensure everne at their organization is aware of the information in the Advisory Notice. If product was further distributed, please forward Safety Notice to all those affected. For questions regarding this recall call 610-219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 158
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-05-05
- Date posted
- 2015-10-27
- Date terminated
- 2017-05-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 (K142434) | Siemens Medical Solutions USA, Inc. | 2014-11-21 |
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |
| ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES (K031764) | Siemens Medical Solutions USA, Inc. | 2003-09-05 |
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |