BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.
FDA device recall Z-0193-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Trionix Research Laboratory Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 76 devices
- Distribution
- Worldwide, including USA, Australia, Egypt, UK, Belgium.
- Date initiated
- 2006-08-01
- Date posted
- 2006-11-16
- Date terminated
- 2008-10-29
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIAD NUCLEAR IMAGING SYSTEM (K892875) | Trionix Research Laboratory, Inc. | 1989-07-20 |