Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall KION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall KIONsee related information
Date Initiated by FirmJanuary 11, 2005
Date PostedApril 14, 2005
Recall Status1 Terminated 3 on June 16, 2005
Recall NumberZ-0710-05
Recall Event ID 31054
510(K)NumberK024213 
Product Classification Mixer, Breathing Gases, Anesthesia Inhalation - Product Code BZR
ProductKION 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. 
FEI Number 3008355164
Recalling Firm/
Manufacturer		 Maquet Inc
1140 Route 22 East
Bridgewater NJ 08807-2912
For Additional Information ContactMr. 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
ActionMCC 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 Commerce40
DistributionThe systems were distributed to hospitals throughout the nation.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BZR
-
-