Device recall: Allura Xper FD10C; System Code: 722001;
Class II FDA enforcement event 98434. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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 Mar 2026. The firm address in the FDA record is in Best. FDA put the recall in Class II. FDA event 98434 has 22 product records. The first FDA enforcement report date is 8 Apr 2026. 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.
Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and…
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
22 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1659-2026 | Allura Xper FD10C; System Code: 722001; | 15 units (7 US, 8 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1660-2026 | ALLURA Xper FD10F; System Code: 722002; | 10 units (8 US, 2 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1661-2026 | ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; | 2291 units (493 US, 1798 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1662-2026 | ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; | 112 units (138 US, 422 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1663-2026 | ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; | 5084 units (1616 US, 3468 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1664-2026 | ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; | 461 units (198 US, 263 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1665-2026 | ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; | 196 units (73 US, 223 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1666-2026 | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; | 4 units (2 US, 2 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1667-2026 | ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; | 2 units (1 US, 1 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1668-2026 | Allura Xper FD20/10; System Code: 722029; | 85 units (20 US, 65 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1669-2026 | Allura Xper FD20/20; System Code: 722038; | 111 units (31 US, 80 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1670-2026 | Allura Xper FD20/20 OR Table; System Code: 722039; | 5 units (OUS only) | Class II | Ongoing | 8 Apr 2026 |
| Z-1671-2026 | Allura Xper FD20/15; System Code: 722058; | 296 units (68 US, 228 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1672-2026 | Allura Xper FD20/15 OR Table; System Code: 722059; | 2 units (2 US, 6 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1673-2026 | Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; | 298 units (27 US, 271 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1674-2026 | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); | 798 units (42 US, 756 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1675-2026 | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; | 670 units (106 US, 564 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1676-2026 | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | 1523 units (322 US, 1201 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1677-2026 | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; | 1994 units (360 US, 1634 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1678-2026 | Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); | 5167 units (1728 US, 3439 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1679-2026 | Azurion 5 M12; System Code: (1)722227, (2)722231; | 345 units (10 US, 335 OUS) | Class II | Ongoing | 8 Apr 2026 |
| Z-1680-2026 | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); | 920 units (168 US, 752 OUS) | Class II | Ongoing | 8 Apr 2026 |
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 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 22Median of the firm: 1
- Events of the firm on the register
- 59
Other events of the firm
Official channels
- FDA enforcement report Z-1659-2026The 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 98434. https://recallregister.com/fda/ii/98434/. 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:
Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and…
- What quantity of product is in FDA event 98434?
- The event has 22 product records. The first record gives this quantity:
15 units (7 US, 8 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.