728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Reported: August 25, 2021 Initiated: June 8, 2021 #Z-2314-2021
Product Description
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
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.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 3 units
- Distribution
- US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades. Recalled by Philips North America Llc. Units affected: 3 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2314-2021.
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