Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interven
FDA device recall Z-2404-2015 · posted 2015-08-18 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.
- Action taken
- A customer advisory notice, dated June 30, 2015, was sent to consignees informing them of the corrective action that would be performed to prevent the possible loss of the image generation function. Siemens plans to contact end users to install a software patch. For questions regarding this recall call 610-219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 586
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-06-30
- Date posted
- 2015-08-18
- Date terminated
- 2016-12-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM (K123529) | Siemens Medical Solutions USA, Inc. | 2013-02-26 |