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U.S. Department of Health and Human Services

Class 2 Device Recall Sienet Cosmos

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  Class 2 Device Recall Sienet Cosmos see related information
Date Initiated by Firm October 03, 2006
Date Posted October 25, 2006
Recall Status1 Terminated 3 on April 23, 2008
Recall Number Z-0069-2007
Recall Event ID 36527
510(K)Number K042832  
Product Classification image archiving and communications system - Product Code LLZ
Product Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
Code Information Model number 10018969. Serial numbers 1001, 1010, 1011, 1028, 1029
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-4500
Manufacturer Reason
for Recall		 Potential loss of images. Images may not successfully be sent to the RAID system.
FDA Determined
Cause 2		 Other
Action The recalling firm has issued a software patch to resolve the issue via Update Instructions HS110/06/S. The Update Instructions direct a Siemens Service Representative to visit the affected sites, install the software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20th, 2006, to the customer to notify them of the issue.
Quantity in Commerce 5 units
Distribution The product was shipped to hospitals in CA, MD, MO, and PA
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 = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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