Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,
Summary
The FDA issued a Class II for Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K1306 by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the syst.
Details
Source
Device Recall
External ID
Z-0012-2026
Action Date
2025-10-08
Status
Ongoing
Category
device
Product Description
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Lot/Code Info: Model Numbers: 722038; UDI-DI: 00884838054226; Serial Numbers: 39, 63, 42, 55, 67, 99, 60, 71, 141, 115, 7, 78, 108, 106, 167, 118, 130, 49, 119, 126, 173, 38, 37, 48, 62, 35, 137, 120, 157, 41, 131, 96, 70, 46, 102, 169, 11, 89, 117, 40, 105, 113, 110, 5, 134, 88, 64, 112, 143, 94, 109, 73, 133, 166, 147, 31, 3, 127, 92, 135, 32, 69, 121, 123, 98, 129, 79, 14, 148, 153, 164, 111, 160, 171, 172, 159, 155, 144, 163, 152, 168, 161, 122, 158, 156, 138, 162, 132, 95, 116, 45, 9, 150, 146, 90, 27, 91, 154, 104, 124, 30, 136, 72, 93, 66, 140, 75, 50, 68, 58, 54, 47, 36, 28, 29;
Quantity Affected: 115 units (34 US, 81 OUS)
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-03
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 168 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 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 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0012-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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