Z-0623-03

e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens...

Name: Z-0623-03 e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2003-02-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-02-10 / Terminated

FDA source

Siemens Medical Solutions USA, Inc. began a recall of e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group... on 2003-02-10. The reason FDA records is "Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0623-03
Status: Terminated
Initiated: 2003-02-10
Posted: 2003-03-06
Terminated: 2004-09-15
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.
FDA root cause: 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.
Product codes and lots: 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.

Product code KPS

K952109Class IIIp500 Nuclear Gamma Camera SystemSiemens Medical Solutions USA, Inc. / cleared 1995-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)