Class 2 Device Recall AXIOM Sensis

• Date Initiated by Firm: July 09, 2004
• Date Posted: October 22, 2004
• Recall Status: Terminated on September 13, 2005
• Recall Number: Z-0036-05
• Recall Event ID: 29826
• 510(K)Number: K020440
• Product Classification: Computer, Diagnostic, Programmable - Product Code DQK
• Product: AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161
• Code Information: 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 Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: possible error calculating valve area with the AXIOM Sensis
• FDA Determined Cause: Other
• Action: The 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 Commerce: 143 units
• Distribution: The 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 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 = DQK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.