Recall Z-0193-2007 ยท KPS System, Tomography, Computed, Emission
Trionix Research Laboratory Inc
BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.
| Date | Nov 16, 2006 (initiated Aug 1, 2006) |
| Status | Terminated |
| Reason | The ball screw on the unit which supports the detector head (which weighs approximately 800 lbs.) could snap resulting in the detector head dropping on the patient. |
| Root cause | Other |
| Action | The recalling firm modified one of the devices in 2002. The remaining device users were telephoned on/about 11/02/2006. To date the recalling firm has not taken any corrective action regarding devices with serial numbers B-102, B-103, B-104 or B-106 thru B-184. |
| Quantity | 76 devices |
| Distribution | Worldwide, including USA, Australia, Egypt, UK, Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892875 | BIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc., Jul 20, 1989 |