Recall Z-0710-05 ยท BZR Mixer, Breathing Gases, Anesthesia Inhalation
Maquet Inc
KION Anesthesia System.
| Date | Apr 14, 2005 (initiated Jan 11, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 40 |
| Distribution | The systems were distributed to hospitals throughout the nation. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024213 | SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 Siemens Medical Solutions USA, Inc., Mar 23, 2004 |