Z-0193-2007

BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System

Name: Z-0193-2007 BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System
Creator: Trionix Research Laboratory Inc
Published: 2006-08-01
License: https://open.fda.gov/license/

Trionix Research Laboratory, Inc. / initiated 2006-08-01 / Terminated

FDA source

Trionix Research Laboratory Inc began a recall of BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System on 2006-08-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0193-2007
Status: Terminated
Initiated: 2006-08-01
Posted: 2006-11-16
Terminated: 2008-10-29
Recalling firm: Trionix Research Laboratory, Inc.
Product: BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.
Product code: KPS System, Tomography, Computed, Emission
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.
FDA 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 in commerce: 76 devices
Distribution: Worldwide, including USA, Australia, Egypt, UK, Belgium.
Product codes and lots: Serial numbers B-102 through B-184

Product code KPS

K892875Class IIBiad Nuclear Imaging SystemTrionix Research Laboratory, Inc. / cleared 1989-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)