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Philips North America Llc Recall 88336

Description: 728333 Spectral CT 7500 -Computed Tomography X-ray system

Philips North America Llc Recall 88336 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2318-2021
Event ID88336
Event Description728333 Spectral CT 7500 -Computed Tomography X-ray system
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Quantity1 unit
Recall ReasonWhen 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.
Device Classification20210825
Device Code InfoSerial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option
Center Classification Date20210818
Recall Initiation Date20210608
Recalling FirmPhilips North America Llc
Initial Notification Letter
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