Recall Z-0053-04 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
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
| Date | Oct 24, 2003 (initiated Sep 5, 2003) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952109 | IP500 NUCLEAR GAMMA CAMERA SYSTEM Siemens Medical Solutions USA, Inc., Aug 23, 1995 |