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U.S. Department of Health and Human Services

Class 2 Device Recall KION

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  Class 2 Device Recall KION see related information
Date Initiated by Firm January 11, 2005
Date Posted April 14, 2005
Recall Status1 Terminated 3 on June 16, 2005
Recall Number Z-0710-05
Recall Event ID 31054
510(K)Number K024213  
Product Classification Mixer, Breathing Gases, Anesthesia Inhalation - Product Code BZR
Product KION Anesthesia System.
Code Information 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
1140 Route 22 East
Bridgewater NJ 08807-2912
For Additional Information Contact Mr. Jamie Yieh
908-947-2311
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BZR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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