FDA · Class II · August 19, 2026
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
Philips Medical Systems Nederland B.v recall: Allura Xper FD
Philips Medical Systems Nederland B.v. is recalling Allura Xper FD – 4,252 units. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on June 29, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Allura Xper FD |
| Brand | Philips Medical Systems Nederland B.v |
| Company | Philips Medical Systems Nederland B.v. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | June 29, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 4,252 units |
| Recall ID | 99378 |
As listed by FDA
Recalled products
- Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
- FDA recall number
- Z-2928-2026
- Codes, lots and dates
- Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. 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- Quantity
- 4,252 units
- Classification
- Class II
Exactly as the agency lists them
Identifiers and details
- FDA event ID
- 99378
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Best, Netherlands
Why it was recalled
The reason the FDA lists: “Firmware issue potentially leading to loss of geometry movements.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Vietnam, Yemen.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99378, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Same brand
Other Philips Medical Systems Nederland B.v recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Aug 19, 2026 |  Philips Medical Systems Nederland B.v recall: Philips Azurion RystemMedical devices · 10872 units | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality … Serious | FDA Class II |
| Aug 19, 2026 | Philips Medical Systems Nederland B.v recall: Philips AzurionMedical devices · 2016 units | Two software related issues: 1) Potential image quality degradation that may lead to delay… Serious | FDA Class II |
All 3 Philips Medical Systems Nederland B.v recalls →
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FAQ
About this recall
Is Philips Medical Systems Nederland B.v Allura Xper FD recalled?
Yes. Philips Medical Systems Nederland B.v. recalled it on June 29, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Firmware issue potentially leading to loss of geometry movements.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
Recalls
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.