Z-0053-04

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

Name: Z-0053-04 e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2003-09-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-09-05 / 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 2003-09-05. The reason FDA records is "The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0053-04
Status: Terminated
Initiated: 2003-09-05
Posted: 2003-10-24
Terminated: 2005-02-24
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--
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 root cause: 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.
Product codes and lots: 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

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)