FDA Medical Device Recalls (openFDA)
Trionix Research Laboratory Inc: BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.
- Recall number
- Z-0193-2007
- 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.
- Status
- Terminated
- Initiated
- 2006-08-01
- Posted
- 2006-11-16
- Terminated
- 2008-10-29
- 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.
- Lot, serial or model codes
- Serial numbers B-102 through B-184
- 510(k) numbers
- ["K892875"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1527587
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28