Class II — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Firmware issue potentially leading to loss of geometry movements. |
| Product | Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system. |
| Quantity | 4,252 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, J… |
| Initiated | 2026-06-29 |
| Classified | 2026-08-10 |
| Recall number | Z-2928-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (Z-2928-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99378/
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