The Recall Desk
HighFDA (Devices)·Z-2034-2025·Announced 2025-07-02

[pending] Spectral CT. Computed tomography X-ray system.

Pending LLM rewrite. Source: FDA_DEVICE Z-2034-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

The recalled product

Product
Spectral CT. Computed tomography X-ray system.
Manufacturer
Philips North America Llc
Category
Medical Device — Devices

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)

  • Part No. 728333
  • UDI: (01)00884838101111(21)10014
  • (01)00884838101111(21)10015
  • (01)00884838101111(21)10016
  • (01)00884838101111(21)10017
  • (01)00884838101111(21)10018
  • (01)00884838101111(21)10019
  • (01)00884838101111(21)10020
  • (01)00884838101111(21)10021
  • (01)00884838101111(21)10022
  • (01)00884838101111(21)10023
  • (01)00884838101111(21)10024
  • (01)00884838101111(21)10025
  • (01)00884838101111(21)10027
  • (01)00884838101111(21)10031
  • (01)00884838101111(21)10032
  • (01)00884838101111(21)10033
  • (01)00884838101111(21)10034
  • (01)00884838101111(21)10035
  • (01)00884838101111(21)10036

Distribution

Distributed in 19 states:

  • AZ
  • CA
  • CO
  • FL
  • GA
  • HI
  • IN
  • KY
  • MA
  • MD
  • MN
  • NY
  • OH
  • OR
  • PA
  • TX
  • VT
  • WA
  • WV

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