CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report
Allura Xper/10 recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Allura Xper/10, distributed nationwide in the US. The recall was initiated on 3 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2624-2025
- FDA event ID
- 97501
- Recalling firm
- Philips Medical Systems Nederl, Best, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2025
- FDA classified
- 25 Sep 2025
- Reported
- 1 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 3 Sep 2025 | Recall initiated by company | |
| 25 Sep 2025 | Classified by FDA | +22 days |
| 1 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Questions about this recall
Why was it recalled?
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Which lots are affected?
Product Codes: (1)722011, (2) 722027, (3) 722005; UDI-DI: (1) 00884838059047, (2) 00884838054196, (3) N/A; Serial numbers: (1) 157, 268, 95, 107, 59, 319, 49, 170, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 87, 255, 171, 362, 168, 275, 344, 324, 163, 103, 215, 328, 286, 81, 293, 294, 224, 117, 334, 338, 146, 145, 266, 21, 202, 165, 367, 372, 340, 318, 98, 211, 158, 271, 204, 246, 206, 321, 295, 104, 217, 265, 261, 125, 282, 216, 333, 329, 230, 198, 244, 292, 180, 183, 314, 337, 341, 376, 377, 378, 259, 347, 287, 99, 233, 156, 71, 77, 188, 223, 238, 153, 129, 278, 118, 186, 108, 89, 258, 310, 274, 139, 141, 86, 300, 88, 309, 227, 220, 242, 166, 299, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 116, 112, 114, 43, 313, (2) 123, 133, 134, 183, 106, 169, 107, 42, 101, 209, 153, 40, 156, 112, 1, 104, 71, 175, 116, 174, 29, 50, 56, 152, 43, 49, 202, 178, 127, 39, 27, 64, 78, 99, 6, 86, 7, 145, 102, 44, 142, 30, 79, 38, 85, 181, 144, 177, 165, 201, 3, 68, 51, 21, 23, 24, 90, 171, 45, 122, 33, 137, 163, 150, 96, 155, 20, 166, 147, 139, 91, 136, 193, 69, 65, 168, 206, 158, 66, 75, 62, 138, 121, 18, 31, 131, 195, 192, 125, 148, 149, 46, 47, 135, 159, 100, 103, 110, 57, 274, 61, 36, 151, 300, 167, 60, 81, 126, 58, 184, 5, 188, 94, 154, 172, 35, 76, 95, 187, 170, 146, 162, 82, 117, 48, 205, 182, 132, (3) 212, 435, 128, 323, 269, 342, 531, 403, 287, 457, 373, 332, 374, 428, 75, 499, 511, 473, TPE, 333, 237, 338, SN545, 159, 100071298SN408, 96;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 97501This product is part of a recall event; the main page for the event is Allura Xper Biplane recalled by Philips Medical Systems.
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