Recall Z-0208-2016 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
| Date | Nov 4, 2015 (initiated Jun 26, 2015) |
| Status | Terminated |
| Reason | Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized. |
| Root cause | Component design/selection |
| Action | The firm, Siemens, sent out an undated "CUSTOMER SAFETY ADVISORY NOTICE" on 04 April 2015 to its consignees informing them of the e.com system safety update. The notice described the product, problem and actions to be taken. The notice stated the following: In order for an injury to occur, the following series of events must be present; 1. The detector configuration angle must be 180 degrees. 2. The detector with the failed brake circuit must be above the patient. 3. The detector with the faulty brake circuit must be under power (in motion). 4. System power must cycle within a very short time |
| Quantity | 32296 e.cam Gamma Camera systems |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, Cameroon, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142006 | SYMBIA 6.0 Siemens Medical Solutions USA, Inc., Aug 21, 2014 |