BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.
FDA Recall Z-0193-2007 · Posted 2006-11-16
Recalling FirmTrionix Research Laboratory Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2006-08-01
Date Terminated2008-10-29
Product Quantity76 devices
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Australia, Egypt, UK, Belgium.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.