Azurion 3 M12 recall
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Why was Azurion 3 M12 recalled?
Possibility of the patient falling from the table related to the mattress used on the patient table.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 263 units (26 US, 237 OUS)
- 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.
- Recall date
- February 26, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)