—#29204

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

FDA product code: KPS--
510(k) numbers: K952109
Affected lot / code info: 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

Why it was recalled

The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 N. Barrington Road, Hoffman Estates, Illinois 60195-5203

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-09-05
Posted by FDA: 2003-10-24
Terminated: 2005-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.