Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to Ceiling mounted L-arm contains a rotation cover that...

Date: November 3, 2023
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. directly.

Affected Products

Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20

Quantity: 3821 units

Why Was This Recalled?

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 154 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report