PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

Hazard

Possibility of the patient falling from the table related to the mattress used on the patient table.

Details from the source

Reason for recall: Possibility of the patient falling from the table related to the mattress used on the patient table. 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, Ecu Quantity: 263 units (26 US, 237 OUS) Lot/code info: 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.

UPC codes

00884838085275, 00884838099203

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.