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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Uroskop Access

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  Class 2 Device Recall Siemens Uroskop Access see related information
Date Initiated by Firm April 30, 2012
Date Posted September 10, 2012
Recall Status1 Terminated 3 on September 20, 2012
Recall Number Z-2341-2012
Recall Event ID 62988
510(K)Number K010942  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Siemens Uroskop Access.

Fluoroscopic, image intensified x-ray system
Code Information Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall		 Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent a Update instructions letter dated April 2012, to all affected customers. The safety instruction letter identified the product the problem and the action needed to be taken by the customer. The update has been completed successfully. The customer has been informed of the benefits of improvements resulting from this update. Further questions please call (610) 219-4834.
Quantity in Commerce 5
Distribution Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.
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 = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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