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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21); 722079 Azurion 7 M20 (01)00884838085268(21); 722223 Azurion 7 M12 (01)00884838099241(21); 722224 Azurion 7 M20 (01)00884838099258(21); 722227 Azurion 5 M12 (01)00884838099227(21); 722228 Azurion 5 M20 (01)00884838099234(21).
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason for Recall:
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21); 722079 Azurion 7 M20 (01)00884838085268(21); 722223 Azurion 7 M12 (01)00884838099241(21); 722224 Azurion 7 M20 (01)00884838099258(21); 722227 Azurion 5 M12 (01)00884838099227(21); 722228 Azurion 5 M20 (01)00884838099234(21).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0559-2024

Related Recalls

The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.

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The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

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