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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 September 22, 2005
Date Posted October 28, 2005
Recall Status1 Terminated 3 on August 23, 2006
Recall Number Z-0092-06
Recall Event ID 33843
510(K)Number K042832  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Sienet Cosmos. Radiological Image Processing. Model number 10018971
Code Information model number 10018971  version VB15C
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		 reference lines appear above actual position
FDA Determined
Cause 2		 Other
Action The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.
Quantity in Commerce 64 units
Distribution The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, 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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