Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an acc
FDA device recall Z-2075-2014 · posted 2014-07-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI
- Action taken
- Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 7
- Distribution
- US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
- Date initiated
- 2014-05-15
- Date posted
- 2014-07-17
- Date terminated
- 2014-12-15
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 (K101119) | Siemens Medical Solutions USA, Inc. | 2010-06-16 |