Class 2 Device Recall Axiom Sensis

• Date Initiated by Firm: February 28, 2003
• Date Posted: July 03, 2003
• Recall Status: Terminated on April 08, 2004
• Recall Number: Z-0979-03
• Recall Event ID: 25930
• 510(K)Number: K020440
• Product Classification: Computer, Diagnostic, Programmable - Product Code DQK
• Product: Axiom Sensis. Programmable Diagnostic Computer
• Code Information: Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Parkway; Malvern PA 19355
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: software problem - erroneous results or system crashes
• FDA Determined Cause: Other
• Action: The recalling firm issued a Customer Safety Advisory Letter to their customers. The letter instructed the customer to insert the letter into their operator''s manual and that updated software would be released in May 2003.
• Quantity in Commerce: 4 units
• Distribution: The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.
• 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