medical MODERATE Updated 2026-10-14

Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5

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Recalled Product

Alphenix INFX-8000C/B5

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Hazard / Issue

Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial no. B5F2532011/UDI: 4987670100192

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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