Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-0009-2026

Z-0009-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

FDA device recall Z-0009-2026 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on September 3, 2025 and is designated Class II. Reason for recall: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. … The recall status is ongoing. Affected quantity: 87 units (21 US, 66 OUS).

Recall Details

Product Type: Devices
Report Date: October 8, 2025
Initiation Date: September 3, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 87 units (21 US, 66 OUS)

Product Description

Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Reason for Recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, 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, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

Code Information

Model Numbers: 722029; UDI-DI: 00884838054219; Serial Numbers: 71, 91, 7, 94, 62, 88, 36, 97, 21, 100, 30, 63, 60, 129, 95, 126, 110, 56, 55, 57, 31, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 14, 127, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 51, 50, 124, 87, 20, 29, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;

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