Summary
The FDA issued a Class II for Allura Xper FD20/15; System Code: 722058; by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch..
Details
Source
Device Recall
External ID
Z-1671-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
Allura Xper FD20/15; System Code: 722058;
Lot/Code Info: System Code: 722058; UDI: 00884838059115; System Serial Number: 100, 239, 305, 259, 203, 373, 111, 38, 23, 290, 124, 274, 340, 366, 162, 186, 4, 196, 156, 285, 277, 65, 168, 56, 178, 138, 212, 249, 257, 337, 265, 109, 134, 71, 238, 190, 219, 197, 325, 24, 123, 319, 378, 61, 205, 149, 264, 167, 365, 199, 278, 215, 288, 254, 94, 304, 279, 171, 82, 85, 202, 99, 182, 22, 200, 129, 59, 172, 110, 399, 72, 332, 92, 142, 67, 106, 335, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 101, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 408, 360, 370, 400, 387, 356, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 331, 379, 418, 421, 369, 420, 397, 357, 393, 388, 108, 211, 125, 126, 301, 30, 354, 355, 159, 139, 128, 81, 58, 96, 343, 177, 115, 18, 19, 311, 386, 291, 327, 220, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;
Quantity Affected: 296 units (68 US, 228 OUS)
Reason for Recall
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-03
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 534 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 239 FDA actions in our database, including 203 recalls and 36 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 239 FDA actions in our database, including 203 recalls and 36 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1671-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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