Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-2317-2021)

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:

728332 IQon Spectral CT-Computed Tomography X-ray system

Product Classification:

Class II

Date Initiated: June 8, 2021

Date Posted: August 25, 2021

Recall Number: Z-2317-2021

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: N/A

Code Information:

Serial Number/UDI: 60001 (01)00884838059542(21)60001, 60005 (01)00884838059542(21)60005, 60015 (01)00884838059542(21)60015, 60017 (01)00884838059542(21)60017, 860026 (01)00884838059542(21)860026, 860035 (01)00884838059542(21)860035, 860053 (01)00884838059542(21)860053 860074 (01)00884838059542(21)860074, 860108 (01)00884838059542(21)860108, 860109 (01)00884838059542(21)860109. Software Version 4.7.7 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