Recall Z-1680-2020— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-02-18, terminated 2021-02-09. It names one FDA 510(k) clearance: K993425. Product: PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13. Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-18
- Terminated
- 2021-02-09
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Reason for recall
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.