e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Syst
FDA device recall Z-0053-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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 Ric
- Date initiated
- 2003-09-05
- Date posted
- 2003-10-24
- Date terminated
- 2005-02-24
- Location
- Hoffman Estates, IL
Monitor recalls programmatically
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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 |