Philips North America Llc Recall 88336
Description: 728333 Spectral CT 7500 -Computed Tomography X-ray system
Philips North America Llc Recall 88336 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2318-2021 |
| Event ID | 88336 |
| Event Description | 728333 Spectral CT 7500 -Computed Tomography X-ray system |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA. |
| Quantity | 1 unit |
| Recall 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. |
| Device Classification | 20210825 |
| Device Code Info | Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option |
| Center Classification Date | 20210818 |
| Recall Initiation Date | 20210608 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
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