Recall Weekly
Moderate riskFDA DeviceClass II

Philips ALLURA Xper FD10/10 X-ray system recalled for foot switch imaging failure

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10/10 X-ray systems where imaging may not start or may work on and off intermittently. This affects 112 systems distributed worldwide, identified by specific serial numbers.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. Locate your system's serial number and check if it matches the affected list provided by Philips
  2. Contact Philips Medical Systems if your system is listed
  3. Follow Philips instructions for inspection or repair of the foot switch
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
112 units (138 US, 422 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1662-2026

In the FDA's words

Description
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. (1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169, 305, 565, 419, 269, 258, 346, 474, 497, 530, 261, 523, 384, 388, 271, 233, 367, 270, 427, 343, 399, 360, 212, 251, 112, 520, 70, 392, 128, 357, 485, 405, 306, 307, 467, 234, 287, 333, 533, 209, 369, 543, 332, 328, 366, 389, 538, 394, 378, 379, 237, 165, 238, 2724, 415, 482, 397, 53, 385, 52, 531, 58, 499, 229, 374, 25, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 511, 428, 500, 463, 464, 14, 459, 416, 359, 487, 74, 457, 564, 469, 72, 125, 494, 519, 373, 76; (2) System Code: 722011; UDI: 00884838059047; System Serial Number: 49, 137, 375, 332, 102, 103, 95, 107, 380, 132, 171, 157, 270, 362, 76, 79, 22, 234, 308, 34, 324, 177, 84, 82, 319, 17, 133, 168, 345, 344, 83, 59, 15, 170, 163, 101, 255, 173, 325, 87, 155, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 186, 300, 213, 372, 41, 55, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 74, 75, 301, 302, 303, 304, 305, 306, 307, 18, 293, 294, 184, 266, 146, 116, 68, 310, 88, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 139, 141, 99, 277, 313, 223, 27, 29, 26, 340, 69, 367, 374, 328, 228, 251, 231, 323, 224, 81, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 377, 376, 378, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 244, 287, 38, 176, 39, 282, 329, 246, 295, 337, 292, 125; (3) System Code: 722027; UDI: 00884838054196; System Serial Number: 351, 332, 1, 71, 319, 43, 101, 29, 50, 112, 240, 241, 175, 298, 280, 107, 183, 202, 164, 153, 335, 288, 342, 134, 156, 265, 306, 307, 152, 106, 169, 203, 234, 209, 267, 284, 263, 127, 116, 174, 39, 49, 56, 120, 123, 133, 305, 246, 255, 40, 178, 104, 42, 266, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 292, 293, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 334, 338, 162, 273, 5, 160, 61, 36, 299, 294, 345, 76, 94, 348, 349, 350, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 165, 81, 126, 268, 356, 244, 55, 86, 254, 6, 117, 362, 271, 186, 259, 236, 201, 275, 135, 277, 58, 249, 148, 149, 38, 47, 316, 27, 274, 80, 64, 205, 223, 270, 181, 221, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 145, 214, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 242, 243, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 21, 23, 24, 65; 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; Affected quantity: 112 units (138 US, 422 OUS)
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

22 products in this recall

Philips X-ray systems recalled for faulty foot switch

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Philips

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