🔍 RecallPedia

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

Class I - Dangerous
🏥 Medical Devices Recalled: January 13, 2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog numbers: (1) 722063, (2) 722221; UDI-DI: (1) 00884838085275, (2) 00884838099203; Serial Numbers: (1) 96, 122, 132, 131, 108, 84, 98, 56, 64, 101, 29, 139, 61, 75, 40, 77, 123, 154, 137, 150, 144, 135, 145, 127, 53, 121, 148, 55, 99, 143, 43, 25, 54, 151, 91, 85, 90, 86, 107, 89, 88, 44, 76, 47, 83, 93, 2, 130, 23, 73, 41, 97, 116, 117, 19, 50, 24, 149, 102, 38, 92, 72, 46, 27, 21, 78, 63, 119, 128, 28, 129, 22, 141, 69, 115, 100, 113, 106, 14, 16, 17, 70, 153, 18, 120, 105, 80, 146, 94, 104, 26, 51, 15, 59, 103, 81, 133, 48, 52, 79, 140, 3, 4, 110, 62, 30, 82, 71, 36, 37; (2) 108, 9, 54, 19, 153, 181, 6, 3, 7, 49, 115, 177, 85, 93, 171, 69, 182, 2, 60, 86, 122, 105, 44, 71, 159, 187, 8, 127, 59, 56, 126, 1, 52, 68, 145, 107, 128, 74, 97, 91, 132, 114, 130, 172, 35, 82, 134, 22, 162, 95, 67, 51, 66, 84, 61, 46, 102, 50, 53, 78, 79, 149, 99, 27, 157, 48, 32, 31, 158, 151, 141, 94, 146, 104, 119, 135, 124, 57, 161, 184, 25, 40, 77, 92, 131, 76, 163, 81, 73, 41, 29, 123, 75, 47, 83, 28, 143, 183, 45, 33, 142, 118, 30, 16, 10, 169, 39, 64, 98, 129, 164, 103, 140, 38, 154, 62, 173, 180, 168, 13, 120, 152, 165, 34, 58, 174, 11, 185, 55, 70, 106, 147, 5, 15, 155, 166, 176, 42, 96, 36, 4, 43, 23, 26, 133, 167, 144, 101 ***Serial Numbers Added 5/2/25*** 178 186, 190, 196, 197.
  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:
Possibility of the patient falling from the table related to the mattress used on the patient table.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

Product Codes/Lot Numbers:

Catalog numbers: (1) 722063, (2) 722221; UDI-DI: (1) 00884838085275, (2) 00884838099203; Serial Numbers: (1) 96, 122, 132, 131, 108, 84, 98, 56, 64, 101, 29, 139, 61, 75, 40, 77, 123, 154, 137, 150, 144, 135, 145, 127, 53, 121, 148, 55, 99, 143, 43, 25, 54, 151, 91, 85, 90, 86, 107, 89, 88, 44, 76, 47, 83, 93, 2, 130, 23, 73, 41, 97, 116, 117, 19, 50, 24, 149, 102, 38, 92, 72, 46, 27, 21, 78, 63, 119, 128, 28, 129, 22, 141, 69, 115, 100, 113, 106, 14, 16, 17, 70, 153, 18, 120, 105, 80, 146, 94, 104, 26, 51, 15, 59, 103, 81, 133, 48, 52, 79, 140, 3, 4, 110, 62, 30, 82, 71, 36, 37; (2) 108, 9, 54, 19, 153, 181, 6, 3, 7, 49, 115, 177, 85, 93, 171, 69, 182, 2, 60, 86, 122, 105, 44, 71, 159, 187, 8, 127, 59, 56, 126, 1, 52, 68, 145, 107, 128, 74, 97, 91, 132, 114, 130, 172, 35, 82, 134, 22, 162, 95, 67, 51, 66, 84, 61, 46, 102, 50, 53, 78, 79, 149, 99, 27, 157, 48, 32, 31, 158, 151, 141, 94, 146, 104, 119, 135, 124, 57, 161, 184, 25, 40, 77, 92, 131, 76, 163, 81, 73, 41, 29, 123, 75, 47, 83, 28, 143, 183, 45, 33, 142, 118, 30, 16, 10, 169, 39, 64, 98, 129, 164, 103, 140, 38, 154, 62, 173, 180, 168, 13, 120, 152, 165, 34, 58, 174, 11, 185, 55, 70, 106, 147, 5, 15, 155, 166, 176, 42, 96, 36, 4, 43, 23, 26, 133, 167, 144, 101 ***Serial Numbers Added 5/2/25*** 178 186, 190, 196, 197.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1153-2025

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Dec 7, 2023 Other Medical Devices Nationwide View Details →