Recall Z-2194-2019— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2019-06-24, terminated 2022-10-06. It names one FDA 510(k) clearance: K123599. Product: Vereos PET/CT Model # 882446, computed tomography x-ray system. 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
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-24
- Terminated
- 2022-10-06
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Vereos PET/CT Model # 882446, computed tomography x-ray system
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.