The Recall Desk
HighFDA (Devices)·Z-1316-2026·Announced 2026-02-18

IQon Spectral CT recalled over rotor fasteners that may be undertorqued

Philips is recalling 52 IQon Spectral CT units because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states unsecured rotor parts may potentially be expelled during gantry rotation, and no such event or injury has been reported.

Plain-English summary

The Philips IQon Spectral CT, product code (REF) 728332, is being recalled by Philips North America Llc.

The record states that as part of the CT system sub assembly, 32 fasteners are used to attach the rotor to the bearing within the gantry, and that 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. The record states that while there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

The record lists 52 units under UDI-DI 00884838059542, with serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow Philips' instructions.

The recalled product

Product
IQon Spectral CT; Product Code (REF): 728332;
Manufacturer
Philips North America Llc
Category
Medical Device — CT scanner
Hazard
Affected units
52

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product Code (REF): 728332
  • UDI-DI: 00884838059542
  • Serial Numbers: 60128
  • 60141
  • 60151
  • 60161
  • 60171
  • 60181
  • 60129
  • 60142
  • 60152
  • 60162
  • 60172
  • 60182
  • 60130
  • 60143
  • 60153
  • 60163
  • 60173
  • 60132

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Philips North America Llc

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Same hazard · fastener torque

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