Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-2318-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

728333 Spectral CT 7500 -Computed Tomography X-ray system

Product Classification:

Class II

Date Initiated: June 8, 2021

Date Posted: August 25, 2021

Recall Number: Z-2318-2021

Event ID: 88336

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.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option

Distribution Pattern:

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

Voluntary or Mandated:

Voluntary: Firm initiated