🔍 RecallPedia

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

Class I - Dangerous
🏥 Medical Devices Recalled: November 12, 2021 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    US: Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109. OUS: Model: S/N UDI: 722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220
  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 North America Llc
Reason for Recall:
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

Product Codes/Lot Numbers:

US: Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109. OUS: Model: S/N UDI: 722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0471-2022

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