Z-0710-05

KION Anesthesia System

Name: Z-0710-05 KION Anesthesia System
Creator: Maquet Inc
Published: 2005-01-11
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2005-01-11 / Terminated / root cause: software

FDA source

Maquet Inc began a recall of KION Anesthesia System on 2005-01-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0710-05
Status: Terminated
Initiated: 2005-01-11
Posted: 2005-04-14
Terminated: 2005-06-16
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: KION Anesthesia System.
Product code: BZR Mixer, Breathing Gases, Anesthesia Inhalation
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.
Root cause tag: software
FDA 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 in commerce: 40
Distribution: The systems were distributed to hospitals throughout the nation.
Product codes and lots: Serial Number: 2034; 3416; 3417; 3418; 3419; 3420; 3027; 0501; 3394; 3395; 3396; 3433; 3444; 3445; 3446; 2355; 2356; 2033; 2035; 1838; 1839; 1840; 1841; 1842; 1873; 1874; 1875; 1876; 1877; 1899; 1900; 1902; 1903; 2132; 2032; 1723; 1724; 1725; 1726; 1727.

Product code BZR

K024213Class IISiemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910 E392e, 65 22 572 E397e, 65 03 655Siemens Medical Solutions USA, Inc. / cleared 2004-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)