Company: Maquet, Inc
Date of Enforcement Report: 4/20/05
Class: II
PRODUCT
KION Anesthesia System. Recall # Z-0710-05.
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.
CODE
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.
RECALLING FIRM/MANUFACTURER
Maquet, Inc., Bridgewater, NJ, by internal task team, updates started on January 11, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
40 systems.
DISTRIBUTION
Nationwide.