e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Syst
FDA device recall Z-0623-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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, De
- Date initiated
- 2003-02-10
- Date posted
- 2003-03-06
- Date terminated
- 2004-09-15
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IP500 NUCLEAR GAMMA CAMERA SYSTEM (K952109) | Siemens Medical Solutions USA, Inc. | 1995-08-23 |