The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0353-2025·Announced 2024-11-20

Philips Zenition 70 Recall Due to Potential Fuse Failure

Philips is recalling Zenition 70 devices because the mains control unit board fuse may blow during start-up or procedures.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential fuse failure without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Philips Zenition 70, Model Number 718133. The recall involves 2,247 units distributed worldwide, including 582 units in the United States.

The recall is being issued because there is a potential for the mains control unit board fuse to blow out during system start-up or during a procedure. This defect could interrupt the device's operation.

Healthcare facilities and users should identify affected units by checking the model number and serial numbers listed in the official recall notice. Users should contact Philips Medical Systems for instructions on how to proceed with the recall and any necessary repairs or replacements.

The recalled product

Product
Philips Zenition 70, Model Number: 718133
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Electrosurgical Unit
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: 718133
  • UDI-DI: (01)00884838091528(21)
  • Serial Numbers: 420
  • 4093
  • 2851
  • 3947
  • 2571
  • 4211
  • 3325
  • 3326
  • 2324
  • 3665
  • 491
  • 480
  • 579
  • 580
  • 581
  • 582
  • 4138
  • 71

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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