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U.S. Department of Health and Human Services

Class 2 Device Recall e.cam

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  Class 2 Device Recall e.cam see related information
Date Initiated by Firm February 10, 2003
Date Posted March 06, 2003
Recall Status1 Terminated 3 on September 15, 2004
Recall Number Z-0623-03
Recall Event ID 25546
510(K)Number K952109  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc.,
Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
Code Information All e.cam towers, serial numbers 00013 through 08543, utilizing e.soft, ICON-S and duet acquisition systems, and e.soft and ICON-S COIN systems.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates IL 60195-5203
For Additional Information Contact Mr. Ron Nolte
847-304-7700
Manufacturer Reason
for Recall		 Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.
FDA Determined
Cause 2		 Other
Action Siemens sent Customer Advisory letters dated 2/10/03 to all e.cam customers. The accounts were informed of the problem with unexpected camera movement when multiple fault cocnditions are presnet, causing the brake system to release and the roation of the detector assemblies, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended release of the radial and rotate brakes. The upgrade will be done free of charge.
Quantity in Commerce 1927 units
Distribution Nationwide, United Arab Emirates, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Camaroon, Canada, Chile, China, Colombia, Republic of Congo, Czech Republic, Denmark, Dominican Republic, El Salvador, Equador, Egypt, France, Finland, Germany, Great Britain, Georgia, Greece, Hong Kong, Honduras, Ireland, Israel, India, Italy, Iraq, Jordan, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Madagascar, Myanmar, Mauritius, Malaysia, Niger, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Potugal, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, Uzbekistan, South Africa and the Netherlands.
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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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