Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, in

FDA device recall Z-1581-2025 · posted 2025-04-21 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Action taken

Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. Philips proposes sending the Electronic Product Radiation Defect notification to customers immediately upon FDA approval of the corrective action plan, and completion of the remaining activities within 4 months of FDA approval of the corrective action plan. This corrective action does not require any customer transportation reimbursement. The following statement is included in the customer communication: The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. Draft of letter provided. Philips commits to notifying the FDA on a monthly basis providing progress with this field correction.

Root cause

Labeling design

Status

Open, Classified

Product code

OWB

Distribution

US

Date initiated

2025-02-25

Date posted

2025-04-21

Location

Cambridge, MA

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