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 AXIOM Sensis

  • 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 AXIOM Sensissee related information
Date Initiated by FirmJuly 09, 2004
Date PostedOctober 22, 2004
Recall Status1 Terminated 3 on September 13, 2005
Recall NumberZ-0032-05
Recall Event ID 29826
510(K)NumberK020440 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
ProductAXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Code Information Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021, 6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641 involves the following serial numbers: 4001-4008 and 4050-4056. Model number 66 34 658 involves the following serial numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055. Model number 66 48 161 involves the following serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactRoland Richter
610-448-1777
Manufacturer Reason
for Recall		possible error calculating valve area with the AXIOM Sensis
FDA Determined
Cause 2		Other
ActionThe recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
Quantity in Commerce143 units
DistributionThe product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
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 = DQK
-
-