The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2034-2025·Announced 2025-07-02

Philips Spectral CT Computed Tomography X-ray System Software

Philips Spectral CT systems with affected software may experience unintended motion of the gantry or table that could lead to contact with operators or patients. Additional software issues may also affect CT performance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall involving a risk-of-harm medical device (unintended motion of gantry/table creating collision hazard with operators and patients); source explicitly states the hazard condition but does not report any illnesses or injuries, placing it at the maximum score per the criterion for theoretical risk-of-harm scenarios.

Plain-English summary

Philips North America LLC is recalling Spectral CT computed tomography X-ray systems due to software issues. Devices with the affected software may experience two unintended motion issues that could result in contact between the gantry or table and the operator or patient. The recall also affects additional software issues that may degrade CT performance.

The affected systems were distributed domestically across 19 U.S. states (Arizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, and West Virginia) and internationally across 38 countries and territories.

Approximately 370 units of the Spectral CT system are affected, identified by Part No. 728333 with multiple serial numbers and UDI codes. Facilities and operators who use these systems should contact Philips North America LLC for information regarding the software update or corrective action.

The recalled product

Product
Spectral CT. Computed tomography X-ray system.
Manufacturer
Philips North America Llc
Category
Medical Device — Imaging Equipment / Computed Tomography
Hazard
Affected units
370

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:

Related recalls

Same manufacturer · Philips North America Llc

See all →

Similar recalls