Z-1157-2025Class I

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY)

Name: Z-1157-2025 Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY)
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-01-13
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-01-13 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY) on 2025-01-13. FDA classified it as Class I and gives the reason as "Possibility of the patient falling from the table related to the mattress used on the patient table". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1157-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-01-13
Posted: 2025-02-20
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Possibility of the patient falling from the table related to the mattress used on the patient table.
FDA root cause: Under Investigation by firm
Action: On January 14, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users " Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. " Follow the additional instructions on the use of the mattress included in Appendix B. These instructions include information for the transfer of the patient and the correct use and positioning of the mattress. The information of this Appendix is being included in an Addendum to the Instructions for Use. Additionally, Philips is creating a Quick Reference Card. The Addendum and the Quick Reference Card will be available as from end of March 2025. Please refer to Appendix C on how to download the Addendum to the Instructions for Use and the Quick Reference Card. " In case that the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through the email account: [email protected] " Please complete and return the Response form attached to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken. " Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative (1- 800-722-9377). 5. Actions planned by Philips Image Guided Therapy Systems to correct the problem Philips is informing customers of this issue through this Urgent Medical Device Correction. Additionally, Philips is releasing an Addendum to the Instructions for Use and a Quick Reference Card that will be available for customers at the end of March 2025. This Urgent Medical Device Correction letter has been reported to the appropriate Regulatory Agencies.
Quantity in commerce: 602 units (94 US, 508 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.
Product codes and lots: Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 00884838116788; Serial Numbers: (1) 26, 150, 190, 278, 69, 141, 115, 221, 148, 46, 36, 42, 98, 123, 277, 92, 103, 192, 81, 57, 70, 225, 71, 131, 234, 109, 250, 114, 41, 214, 172, 173, 163, 104, 132, 147, 208, 244, 75, 133, 151, 188, 134, 22, 23, 268, 100, 101, 138, 54, 55, 276, 275, 105, 95, 32, 112, 97, 243, 224, 45, 108, 202, 113, 127, 76, 176, 165, 271, 272, 47, 256, 187, 154, 157, 265, 238, 207, 58, 169, 231, 226, 33, 159, 40, 120, 44, 121, 31, 28, 195, 196, 197, 179, 183, 185, 50, 78, 27, 85, 39, 91, 93, 94, 96, 239, 72, 119, 137, 189, 193, 117, 118, 89, 90, 167, 102, 84, 199, 73, 178, 129, 229, 252, 86, 79, 170, 227, 145, 63, 61, 49, 200, 21, 51, 194, 38, 186, 87, 56, 161, 110, 130, 80, 171, 245, 88, 175, 198, 139, 99, 37, 264, 266, 209, 255, 140, 59, 30, 206, 60, 156, 191, 142, 143, 144, 274, 52, 53, 107, 29, 232, 260, 64, 35, 203, 74, 48, 149, 251, 233, 222, 262, 273, 270, 218, 235, 111, 146, 237, 43, 68, 210, 211, 212, 213, 34, 254, 168; (2) 259, 260, 55, 268, 147, 375, 404, 112, 376, 228, 229, 453, 53, 72, 71, 300, 157, 340, 28, 207, 216, 217, 68, 177, 291, 299, 29, 249, 227, 289, 354, 148, 205, 235, 41, 141, 262, 37, 298, 331, 104, 46, 111, 84, 208, 122, 110, 233, 175, 153, 206, 456, 393, 387, 189, 200, 218, 345, 346, 114, 173, 431, 149, 258, 184, 237, 385, 167, 14, 364, 4, 398, 30, 231, 103, 38, 178, 1, 321, 326, 313, 320, 180, 116, 107, 342, 350, 373, 372, 343, 348, 349, 351, 186, 195, 302, 301, 170, 171, 82, 210, 330, 307, 73, 93, 108, 143, 15, 62, 361, 119, 286, 89, 90, 77, 369, 161, 179, 131, 132, 20, 155, 191, 244, 245, 212, 323, 27, 106, 35, 150, 317, 88, 118, 100, 163, 337, 139, 165, 166, 137, 138, 247, 162, 9, 67, 94, 95, 40, 391, 91, 12, 11, 213, 272, 117, 21, 54, 74, 64, 192, 204, 85, 238, 341, 125, 190, 16, 363, 80, 311, 275, 44, 370, 334, 70, 303, 75, 353, 360, 36, 282, 57, 115, 224, 377, 10, 316, 198, 424, 335, 34, 236, 23, 325, 322, 154, 211, 332, 127, 355, 69, 60, 61, 279, 402, 329, 278, 63, 277, 432, 281, 98, 197, 151, 379, 76, 194, 222, 13, 59, 280, 371, 164, 359, 193, 430, 319, 32, 121, 86, 240, 58, 266, 18, 19, 92, 221, 105, 160, 39, 42, 120, 219, 187, 396, 446, 367, 242, 423, 257, 312, 327, 152, 447, 448, 47, 48, 52, 333, 324, 392, 365, 83, 96, 255, 256, 159, 234, 128, 134, 135, 226, 223, 386, 287, 309, 310, 414, 99, 413, 246, 8, 426, 420, 315, 293, 169, 123, 220, 79, 201, 196, 31, 384, 87, 283, 374, 421, 422, 267, 454, 439, 284, 395, 146, 427, 314, 450, 140, 241, 306, 133, 158, 230, 269, 145, 232, 109, 338, 362, 168, 368, 292, 56, 433, 296, 5, 124, 290, 43, 248, 276, 17, 243, 142, 144, 274, 7, 65, 66, 214 ****Serial Numbers Added 5/2/2025**** 400, 405, 434, 435, 251, 252, 253, 254, 366; (3) OUS ONLY 10, 6, 7, 5, 4, 14 ****Serial Numbers Added 5/2/2025**** 3, 8, 9, 13, 17, 18, 19, 20, 21, 23, 24, 25, 28, 33, 34, 35, 39, 41, 44, 45, 47, 49, 52, 53, 54, 56, 58, 65, 70, 72.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1157-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1142-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1143-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1144-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1145-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1146-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1147-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1148-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1149-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1150-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1151-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1152-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1153-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1154-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1155-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1156-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1157-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1158-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1159-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1160-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1161-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)