Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1317-2026 — Spectral CT; Product Code (REF): 728333;

U.S. FDA — Device Enforcement · United States · 2026-01-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1317-2026
Date of alert
2026-01-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838101111
Reported risk: As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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