Recall Z-2315-2021— Philips North America Llc
Class II · Terminated
Class II FDA medical device recall by Philips North America Llc, initiated 2021-06-08, terminated 2023-08-10. It names one FDA 510(k) clearance: K160743. Product: Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system. Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-08
- Terminated
- 2023-08-10
- Firm location
- Cambridge, MA, 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
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Reason for recall
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.