Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 8/14/2019
Class II
PRODUCT
Ingenuity CT, Model # 728326, computed tomography x-ray system
- Recall Number: Z-2186-2019
Ingenuity Core128 Model # 728323, computed tomography x-ray system
- Recall Number: Z-2187-2019
Ingenuity Core Model # 728321, computed tomography x-ray system
- Recall Number: Z-2188-2019
iCT, Model # 728306, computed tomography x-ray system
- Recall Number: Z-2189-2019
iCT SP Model # 728311, computed tomography x-ray system
- Recall Number: Z-2190-2019
Brilliance 64 Model # 728231, computed tomography x-ray system
- Recall Number: Z-2191-2019
IQon Spectral CT Model # 728332, computed tomography x-ray system
- Recall Number: Z-2192-2019
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
- Recall Number: Z-2193-2019
Vereos PET/CT Model # 882446, computed tomography x-ray system
- Recall Number: Z-2194-2019
REASON
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc on 6/24/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
92
DISTRIBUTION
US Nationwide and International