Device product
MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.
Z-0927-2017
Product summary
- Firm
- Bayer Healthcare
- Event
- Event 75736
- Status
- Terminated
- Classification
- Class II
- Quantity
- 178,982 (86,172 units in U.S.)
- Official record key
device-enforcement:Z-0927-2017
Official wording
Reason: Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted.
Code information: Device Listing # D053816
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
particulates