Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for
FDA device recall Z-1846-2015 · posted 2015-06-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.
- Action taken
- Siemens sent an Important Customer Safety Notice letter dated May 22, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter also informed customers that Siemens would contact them to schedule the installation of a software update to resolve the problem.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 475
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-05-22
- Date posted
- 2015-06-25
- Date terminated
- 2016-12-13
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE/ZEEGO SW VC21 (K141574) | Siemens Medical Solutions USA, Inc. | 2014-09-05 |