KION Anesthesia System.
FDA device recall Z-0710-05 · posted 2005-04-14 · Terminated
Recall details
- Recalling firm
- Maquet Inc
- Reason for recall
- Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.
- Action taken
- MCC has assigned an internal task team to manage plan and perform the correction ofthe installed base of KION (intended for clinical use) in US. Updates started on January 11, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZR
- Quantity affected
- 40
- Distribution
- The systems were distributed to hospitals throughout the nation.
- Date initiated
- 2005-01-11
- Date posted
- 2005-04-14
- Date terminated
- 2005-06-16
- Location
- East Bridgewater, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 (K024213) | Siemens Medical Solutions USA, Inc. | 2004-03-23 |