Recall Z-0992-2013— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-11-26, terminated 2013-12-24. It names one FDA 510(k) clearance: K090745. Product: Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system. Reason: In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-26
- Terminated
- 2013-12-24
- 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
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
Reason for recall
In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.