Date Initiated by Firm | May 17, 2004 |
Date Posted | September 14, 2004 |
Recall Status1 |
Terminated 3 on April 11, 2005 |
Recall Number | Z-1446-04 |
Recall Event ID |
29464 |
510(K)Number | K020440 |
Product Classification |
Computer, Diagnostic, Programmable - Product Code DQK
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Product | AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637 |
Code Information |
Serial Numbers 1002, 1034, 1100-1253, 1300-1504 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
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For Additional Information Contact | Roland Richter 610-448-1777 |
Manufacturer Reason for Recall | Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab. |
FDA Determined Cause 2 | Other |
Action | The recalling firm issued a Customer Safety Advisory to their customers via certified mail on 5/17/04 to inform them of the problem. The advisory provides Update Instructions AX031/04/S to prevent this problem from occurring until the software upgrade is installed to correct the problem. |
Quantity in Commerce | 234 units |
Distribution | The product was shipped to 43 medical facilities nationwide and one government account in KY. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQK
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