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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 September 05, 2003
Date Posted October 24, 2003
Recall Status1 Terminated 3 on February 24, 2005
Recall Number Z-0053-04
Recall Event ID 27105
510(K)Number K952109  
Product Classification unknown device name - 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 models: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7332625, 7332633, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823979; serial numbers 1 through 9091
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates IL 60195-5203
For Additional Information Contact Mr. Ron Nolte
847-304-7516
Manufacturer Reason
for Recall		 The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.
FDA Determined
Cause 2		 Other
Action Siemens sent Important Safety Customer Advisory letters dated 8/27/03 to all e.cam customers on 9/5-12/03. The accounts were informed of the problem with the detector''s radial brake not being applied properly, allowing slow, unintended downward motion of the detector that could result in injury to the patient or operator, and were advised not to leave the patient unattended while on the pallet and not to leave the patient under the detector upon completion of the study. The customers were advised that they would be contacted by their Siemens service provider to schedule a mandatory update to the e.cam to correct the problem. The upgrade will be done free of charge.
Quantity in Commerce 2,386 units
Distribution Nationwide, United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Republic of Congo, Costa Rica, Czech Republic, Denmark, Dominican Republic, El Salvador, Ecuador, Egypt, France, Finland, Germany, Great Britain, Georgia, Greece, Hong Kong, Honduras, Ireland, India, Italy, Iran, Iraq, Jordan, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Macedonia, Madagascar, Myanmar, Mauritius, Malaysia, Nepal, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, Ukraine, Uzbekistan, Zimbabwe, South Africa and the Netherlands.
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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