e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
Recall
- Recall Number
- Z-1687-2012
- Event Number
- 61672
- Firm
- Siemens Medical Solutions USA, Inc.
- FEI Number
- 1000514697
- Product Code
- KPS
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- May 15, 2012
- Posted
- May 30, 2012
- Terminated
- December 23, 2016
- Address
- 2501 Barrington Rd, Hoffman Estates, IL, 60195-2061
Description
e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys
On May 15, 2012, Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated April 11, 2012 to all affected customers. The letters informed customers of the potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. Customers were informed that a Siemens Service Engineer will be inspecting the radial drive gear on their camera system to ensure it is functioning correctly. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at 800-888-7436.
Worldwide Distribution, US (Nationwide) and the countries of Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Republic of Korea, Mexico, Netherlands, Portugal, Spain, Taiwan and the United Kingdom.
137 units