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Azurion recallZ-1679-2026 · Philips Medical Systems Nederland B.V. · initiated Mar 3, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

FDA root cause category: Device Design

What the company is doing

On March 3, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue and follow the instructions below. 2. Perform the daily check before starting the first procedure, as described in the device labelling 3. Should you experience a foot switch activation issue, please report it to your local Philips representative. 4. In case 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 your local Philips representative. 5. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 6. Complete and return the response form included in this Urgent Medical Device Correction letter 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.

Recall details

Recall number
Z-1679-2026
Status
Open, Classified
Initiated by the company
Mar 3, 2026
Posted by the FDA
Mar 27, 2026
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
345 units (10 US, 335 OUS)
Product code
OWB
Distribution
Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen;

Product description

Azurion 5 M12; System Code: (1)722227, (2)722231;

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

(1) System Code: 722227; UDI: 00884838099227; System Serial Number: 265, 135, 88, 276, 264, 271, 63, 238, 360, 23, 127, 159, 197, 149, 54, 56, 230, 192, 156, 250, 98, 31, 128, 81, 24, 37, 320, 179, 270, 151, 53, 246, 245, 84, 38, 28, 29, 170, 30, 338, 324, 108, 305, 168, 172, 356, 346, 62, 236, 25, 313, 339, 104, 321, 59, 109, 101, 19, 155, 99, 285, 247, 261, 298, 177, 138, 337, 157, 158, 228, 249, 61, 287, 55, 239, 306, 215, 336, 213, 76, 216, 73, 318, 353, 65, 167, 41, 85, 191, 20, 226, 102, 40, 87, 163, 83, 251, 268, 309, 310, 316, 290, 272, 5, 6, 7, 218, 36, 75, 195, 43, 345, 116, 18, 153, 351, 352, 14, 15, 120, 262, 204, 258, 326, 348, 17, 141, 114, 103, 355, 113, 110, 315, 21, 161, 194, 105, 173, 174, 64, 49, 71, 91, 187, 166, 210, 219, 222, 273, 205, 280, 300, 256, 335, 121, 80, 123, 243, 344, 308, 22, 140, 90, 142, 69, 200, 72, 362, 242, 323, 331, 136, 269, 137, 77, 89, 294, 181, 234, 95, 2, 111, 221, 293, 165, 342, 1, 12, 16, 257, 330, 67, 340, 260, 148, 281, 284, 248, 333, 199, 183, 106, 253, 145, 164, 241, 52, 26, 233, 301, 211, 154, 217, 332, 334, 44, 198, 297, 206, 292, 130, 58, 203, 47, 48, 107, 93, 125, 240, 122, 118, 112, 46, 176, 92, 252, 184, 57, 202, 100, 115, 133, 350, 263, 3, 32, 175, 229, 304, 124, 307, 220, 79, 60, 311, 146, 147, 319, 188, 74, 8, 9, 94, 134, 82, 143, 86, 286, 96, 227, 231, 329, 126, 162, 299, 35, 11, 259, 180, 160, 196, 322, 208, 282, 13, 178, 4, 132, 131, 209, (2) System Code: 722231; UDI: 00884838099258; System Serial Number: 13, 52, 49, 50, 41, 68, 21, 53, 67, 47, 3, 17, 18, 25, 72, 87, 93, 94, 34, 69, 61, 26, 80, 6, 7, 8, 4, 5, 60, 12, 63, 73, 14, 48, 56, 28, 66, 75, 81, 45, 20, 19, 51, 29, 27, 11, 35, 62, 54, 33, 92, 1, 2, 32, 59;

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98434).

Sources and updates

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