Home / Recalls / Philips North America, LLC / Z-3023-2020

Z-3023-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
October 7, 2020
Initiation Date
November 20, 2019
Termination Date
April 4, 2024
Voluntary/Mandated
FDA Mandated
Product Quantity
71

Product Description

ProxiDiagnost N90

Reason for Recall

Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

Distribution Pattern

United States

Code Information

All ProxiDiagnost N90 systems are affected.

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  • 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)
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  • Z-1210-2026 Class II — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M (December 3, 2025)
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  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
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