Recall Z-1214-2012 ยท KPS System, Tomography, Computed, Emission
Spectrum Dynamics
D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM DYNAMICS --- Spectrum Dynamics (Israel) Ltd. 22 Bareket St. North Industrial Park, P.O. Box 3033, Caesarea, 30889 Israel D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images thr
| Date | Mar 21, 2012 (initiated Jul 15, 2011) |
| Status | Terminated |
| Reason | The firm received a report related to the detector housing on the D-SPECT Cardiac Scanner. Specifically, it was reported that if the detector housing securing mechanism is compromised, the detector housing may pull away from its secured position on the gantry and potentially come into contact with a patient. The reported event was discovered during set up and thus did not involve a patient or p |
| Root cause | Nonconforming Material/Component |
| Action | Spectrum Dynamics sent a "Voluntary Field Correction" letter dated July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken. To implement this fix, a BC Technical Field Service Engineer contacted users to schedule a service visit. In the meantime, Spectrum Dynamics did not believe that this issue warranted the discontinuation of use of the D-SPECT Cardiac Scanner. However, in an abundance of caution, if the detector housing appeared to be loose, or appeared to be disconnecting from the gantry, do not use the system. Please c |
| Quantity | Domestic- 35 units, Foreign - 7 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of France and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072468 | MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM Spectrum Dynamics , Ltd., Oct 1, 2007 |