Recall archive / FDA device enforcement
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). — FDA record Z-1155-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
- Reason
- Possibility of the patient falling from the table related to the mattress used on the patient table.
- Classification
- Class I
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 282 units (9 US, 273 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1155-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1) 276, 238, 264, 63, 88, 135, 261, 19, 62, 83, 171, 191, 240, 133, 100, 93, 202, 115, 46, 134, 56, 53, 151, 99, 55, 54, 157, 158, 28, 241, 234, 164, 82, 299, 32, 12, 16, 272, 72, 64, 242, 176, 95, 2, 286, 75, 145, 71, 262, 143, 36, 120, 112, 5, 6, 7, 74, 188, 253, 280, 40, 87, 102, 146, 147, 77, 122, 141, 14, 15, 4, 163, 47, 48, 3, 1, 13, 123, 86, 269, 92, 173, 174, 121, 204, 258, 126, 245, 231, 81, 199, 166, 308, 105, 124, 49, 31, 26, 108, 247, 287, 170, 61, 292, 183, 168, 197, 195, 194, 149, 138, 140, 43, 273, 21, 17, 210, 22, 37, 221, 218, 219, 114, 101, 217, 220, 111, 294, 59, 85, 160, 67, 148, 96, 30, 20, 29, 263, 196, 137, 84, 236, 198, 118, 304, 23, 172, 230, 38, 159, 187, 125, 73, 60, 203, 211, 91, 52, 226, 216, 161, 128, 44, 206, 233, 103, 243, 260, 80, 281, 154, 252, 127, 205, 180, 106, 79, 98, 104, 293, 110, 113, 109, 177, 248, 227, 94, 259, 229, 301, 222, 162, 153, 300, 107, 167, 200, 142, 90, 69, 251, 268, 290, 309, 310, 316, 256, 228, 57, 184, 116, 165, 282, 178, 11, 35, 209, 132, 131, 58, 130, 18, 8, 9, 215, 249, 41, 270, 179, 24, 285, 305, 250, 25, 298, 156, 76, 155, 65, 213, 192, 239, 315, 89, 175, 257, 246, 136, 307, 181 ****Serial Numbers Added 5/2/2025**** 265, 271, 360, 311, 313, 318, 319, 320, 321, 323, 324, 329, 330, 331, 332, 333, 334, 335, 337, 339, 346, 350, 352, 355. (2) OUS ONLY 2, 3. ****Serial Numbers Added 5/2/2025**** 1, 4, 5, 11, 20. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 26, 2025
- Recall initiation date
- Jan 13, 2025
- Center classification date
- Feb 20, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.