The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0352-2025·Announced 2024-11-20

Philips Zenition 50 Medical Imaging Device May Experience Electrical Fuse Failure

Philips Zenition 50 imaging systems may experience mains control unit fuse failure during startup or procedures. The defect could cause equipment malfunction.

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 medical device with a potential equipment failure hazard that could interrupt patient imaging procedures. No illnesses or injuries have been reported, placing this at High severity per the rubric threshold for risk-of-harm medical devices without reported incidents.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Zenition 50 medical imaging device (Model 718096) due to a potential defect in the mains control unit board fuse. The fuse may blow out during system startup or during patient imaging procedures.

The recalled devices were distributed worldwide, including 156 units in the United States and 29 in Canada. If the fuse fails during operation, the equipment may malfunction, potentially interrupting medical imaging procedures and delaying patient care. No injuries or illnesses have been reported to date.

Healthcare facilities and operators of affected devices should contact Philips Medical Systems for service information and corrective actions. Operators should monitor equipment for signs of malfunction during startup and procedures.

The recalled product

Product
Philips Zenition 50, Model Number: 718096
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Imaging Equipment
Hazard

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)

  • Model Number: 718096
  • UDI-DI: (01)00884838091535(21)
  • Serial Numbers: 792
  • 1762
  • 1763
  • 1748
  • 236
  • 1310
  • 1311
  • 1764
  • 1078
  • 1759
  • 1760
  • 1761
  • 317
  • 1297
  • 75
  • 73
  • 939
  • 1517

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 2 products in this recall →

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