OtherMOU
ALPHA IV REV. 2,30MM ACTIVE TRANSFER DEVICE
Received Jan 23, 2002 · Event occurred Jan 18, 2002
Report 1062385-2002-00003 · MDR key 374296
Device
Generic name
Transfer Device
Manufacturer
Novoste CorporationModel number
A1732Catalog number
WLC-0001-032
Lot number
NA
Product problems
- Calibration Error
Patient
*
Narrative
Description of Event or Problem
UPON RECEIPT OF BETA-CATH SYSTEM, CUSTOMER PERFORMED AN INDEPENDENT DOSE RATE VERIFICATION WHICH YIELDED RESULTS APPROXIMATELY 10% DIFFERENT FROM THE CALIBRATION CERTIFICATE VALUE.
Remedial action
- Recall