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U.S. Department of Health and Human Services

Class 2 Device Recall 3D TOP Ceiling Stand

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  Class 2 Device Recall 3D TOP Ceiling Stand see related information
Date Initiated by Firm November 30, 2005
Date Posted December 31, 2005
Recall Status1 Terminated 3 on July 19, 2006
Recall Number Z-0335-06
Recall Event ID 34191
510(K)Number K802200  
Product Classification Tube Mount, X-Ray, Diagnostic - Product Code IYB
Product 3D TOP Ceiling Stand. X-Ray System model number 8773673
Code Information Model number 8773673
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		 screws on the rollers may become loose
FDA Determined
Cause 2		 Other
Action The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching.
Quantity in Commerce 460 units
Distribution The products were shipped to hospitals and medical facilities nationwide.
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 = IYB and Original Applicant = SIEMENS CORP.
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