Home / Recalls / Philips North America Llc / Z-2317-2021

Z-2317-2021 Class II Terminated

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
June 8, 2021
Termination Date
August 10, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

728332 IQon Spectral CT-Computed Tomography X-ray system

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.

Distribution Pattern

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

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

Other recalls by Philips North America Llc

  • Z-1315-2026 Class II — Brilliance iCT; Product Code (REF): 728306; (January 7, 2026)
  • Z-1318-2026 Class II — Spectral CT 7500 on Rails; Product Code (REF): 728334; (January 7, 2026)
  • Z-1317-2026 Class II — Spectral CT; Product Code (REF): 728333; (January 7, 2026)
  • Z-1316-2026 Class II — IQon Spectral CT; Product Code (REF): 728332; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
  • Z-1033-2026 Class II — Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. (December 12, 2025)
  • Z-1210-2026 Class II — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M (December 3, 2025)
  • Z-1215-2026 Class II — SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S (December 3, 2025)
  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
  • Z-1207-2026 Class II — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW (December 3, 2025)