Device recall: Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859…
Class II FDA enforcement event 97502. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. started this device recall on 3 Sep 2025. The firm address in the FDA record is in Best. FDA put the recall in Class II. FDA event 97502 has 15 product records. The first FDA enforcement report date is 8 Oct 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil,…
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
15 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0001-2026 | Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 2 units (US only) | Class II | Ongoing | 8 Oct 2025 |
| Z-0002-2026 | Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 2317 units (497 US, 1820 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0003-2026 | Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 585 units (145 US, 440 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0004-2026 | Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 2 units (1 US, 1 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0005-2026 | Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 5067 units (1626 US, 3441 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0006-2026 | Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 501 units (212 US, 289 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0007-2026 | Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 4 units (2 US, 2 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0008-2026 | Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 298 units (72 US, 226 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0009-2026 | Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 87 units (21 US, 66 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0010-2026 | Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 300 units (69 US, 231 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0011-2026 | Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 8 units (2 US, 6 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0012-2026 | Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 115 units (34 US, 81 OUS) | Class II | Ongoing | 8 Oct 2025 |
| Z-0013-2026 | Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 5 units (OUS only) | Class II | Ongoing | 8 Oct 2025 |
| Z-0014-2026 | Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 53 units (OUS only) | Class II | Ongoing | 8 Oct 2025 |
| Z-0015-2026 | Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; | 313 units (OUS only) | Class II | Ongoing | 8 Oct 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 15Median of the firm: 1
- Events of the firm on the register
- 59
Other events of the firm
Official channels
- FDA enforcement report Z-0001-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 97502. https://recallregister.com/fda/ii/97502/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil,…
- What quantity of product is in FDA event 97502?
- The event has 15 product records. The first record gives this quantity:
2 units (US only)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.