Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-2315-2021)

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:

Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Product Classification:

Class II

Date Initiated: June 8, 2021

Date Posted: August 25, 2021

Recall Number: Z-2315-2021

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: 2 units

Code Information:

Model: 728321 S/N UDI: 40012 (01)00884838059498(21)40012 Model: 728332 40004 (01)00884838059504(21)40004 Software Version: 4.1.10 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