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U.S. Department of Health and Human Services

Class 2 Device Recall Modularis URO

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  Class 2 Device Recall Modularis URO see related information
Date Initiated by Firm October 01, 2006
Date Posted November 14, 2006
Recall Status1 Terminated 3 on May 13, 2008
Recall Number Z-0168-2007
Recall Event ID 36673
510(K)Number K033335  
Product Classification urological table - Product Code MMZ
Product Modularis URO urological table Model number 5531012
Code Information Model number 5531012, serial numbers 01001 to 01345
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 pinch point with the patient table
FDA Determined
Cause 2		 Other
Action The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions SPO23/06/S. This letter, to be inserted in the system Operator Manual, reminds customers of the potential pinch point and provides a suggestion to avoid its occurrence.
Quantity in Commerce 59 units
Distribution 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 = MMZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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