Reported Feb 18, 2026 · Ongoing

Spectral CT; Product Code (REF): 728333;

Philips North America LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

  • Spectral CT
  • Product Code (REF)728333
Lot codes and dates
  • Product Code (REF)728333
  • UDI-DI00884838101111
  • Serial Numbers

    283 of 283 codes

    • 10055
    • 10075
    • 10086
    • 10096
    • 10106
    • 10116
    • 10126
    • 10136
    • 10146
    • 10156
    • 10166
    • 10176
    • 10186
    • 10196
    • 10206
    • 10217
    • 10227
    • 10237
    • 10247
    • 10257
    • 10267
    • 10277
    • 10289
    • 10302
    • 10314
    • 12009
    • 12019
    • 12029
    • 396013
    • 10056
    • 10076
    • 10087
    • 10097
    • 10107
    • 10117
    • 10127
    • 10137
    • 10147
    • 10157
    • 10167
    • 10177
    • 10187
    • 10197
    • 10207
    • 10218
    • 10228
    • 10238
    • 10248
    • 10258
    • 10268
    • 10278
    • 10290
    • 10303
    • 12000
    • 12010
    • 12020
    • 12030
    • 398003
    • 10057
    • 10077
Amount recalled
283 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.