Device Recall Triumph CT and Triumph II CT scanners 의 리콜

Recall

74838

Class 2

Z-2833-2016

2016-05-24

Terminated

United States

2016-10-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148565

The firm has determined that several triumph/triumph ii research ct scanners produced by northridge trimodality imaging, inc dba trifoillmaging (or by gamma medica-ideas, inc and field upgraded with a replacement x-ray tube) may be out of compliance with 21 cfr 1020.40 (cabinet x-ray standards).

TriFoil lmaging planned action to bring defect into Compliance: 1. All repairs were performed at customer facilities. Customers were contacted by phone to arrange a convenient repair time. 2. TriFoil service engineers installed a collimator on each of the affected cabinet x-ray systems to bring their emission rates into compliance with the emission limit in the performance standard. 3. Full radiation surveys were performed, at maximum exposure settings, to verify each repair was effective. 4. All costs associated with the repair and follow-up testing were paid directly by TriFoil Imaging. CDRH approves the CAP and understands that the CAP was completed on August 29, 2016. For further questions please call (818) 709-2468.