—#26012

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 — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K952109
Affected lot / code info: 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.

Why it was recalled

Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.

Root cause (FDA determination)

Other

Action the firm took

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.

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, 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.

Timeline

Recall initiated: 2003-02-10
Posted by FDA: 2003-03-06
Terminated: 2004-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.