Philips Medical Systems Nederland B.v. Allura Xper FD. Model Numbers: 722026 recall: Firmware issue potentially leading to loss of geometry movements
Firmware issue potentially leading to loss of geometry movements.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: Firmware issue potentially leading to loss of geometry movements.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2928-2026
- Published
- August 19, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Philips Medical Systems Nederland B.v.
- Product type
- Medical devices
- Units affected
- 4,252 units
- Distribution
- Nationwide
- Made in
- Netherlands
- Lot / code info
- Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690, (01)00884838054202(21)928, (01)00884838054189(21)155, (01)00884838054202(21)317, (01)00884838054202(21)1774, (01)00884838054202(21)2502, (01)00884838054202(21)869, (01)00884838054202(21)668, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054202(21)406, (01)00884838054202(21)540, (01)00884838054202(21)548, (01)00884838054202(21)1017, (01)00884838054202(21)590, (01)00884838054189(21)654, (01)00884838054189(21)786, (01)00884838054196(21)216, (01)00884838054196(21)230, (01)00884838054202(21)596, (01)00884838054202(21)1957, (01)00884838054202(21)110, (01)00884838054202(21)2261, (01)00884838054189(21)1132, (01)00884838054226(21)115, (01)00884838059115(21)259, (01)00884838054202(21)173, (01)00884838054202(21)866, (01)00884838054202(21)1310, (01)00884838059115(21)203, (01)00884838054202(21)1043, (01)00884838054189(21)458, (01)00884838054202(21)466, (01)00884838054226(21)42, (01)00884838054202(21)1077, (01)00884838059115(21)373, (01)00884838054202(21)877, (01)00884838054202(21)896, (01)00884838054202(21)987, (01)00884838054202(21)995, (01)00884838054202(21)1343, (01)00884838054202(21)1439, (01)00884838059115(21)111, (01)00884838054202(21)895, (01)00884838054202(21)265, (01)00884838054202(21)305, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054196(21)1, (01)00884838054202(21)1154, (01)00884838054196(21)71, (01)00884838054202(21)1000, (01)00884838054202(21)1909, (01)00884838054202(21)121, (01)00884838054189(21)436, (01)00884838054202(21)1716, (01)00884838054202(21)1983, (01)00884838054202(21)784, (01)00884838054202(21)2061, (01)00884838054202(21)729, (01)00884838054189(21)1338, (01)00884838054202(21)1393, (01)00884838054189(21)1068, (01)00884838054189(21)233, (01)00884838054202(21)525, (01)00884838054202(21)1948, (01)00884838054202(21)1656, (01)00884838054189(21)78, (01)00884838054202(21)209, (01)00884838054202(21)825, (01)00884838054202(21)1461, (01)00884838054202(21)408, (01)00884838059115(21)38, (01)00884838054202(21)570, (01)00884838054202(21)218, (01)00884838054202(21)734, (01)00884838054202(21)1050, (01)00884838054202(21)1751, (01)00884838054202(21)454, (01)00884838054202(21)1428, (01)00884838054219(21)57, (01)00884838054189(21)432, (01)00884838054202(21)666, (01)00884838054219(21)7, (01)00884838054189(21)224, (01)00884838054202(21)488, (01)00884838054226(21)108, (01)00884838054202(21)1094, (01)00884838054202(21)169, (01)00884838059115(21)23, (01)00884838054202(21)2173, (01)00884838054202(21)1214, (01)00884838054202(21)52, (01)00884838054202(21)66, (01)00884838054202(21)493, (01)00884838054202(21)994, (01)00884838054202(21)373, (01)00884838059115(21)290, (01)00884838054202(21)1213, (01)00884838054226(21)173, (01)00884838054202(21)339, (01)00884838054202(21)234, (01)00884838054189(21)93, (01)00884838054189(21)796, (01)00884838054189(21)1072, (01)00884838054202(21)1836, (01)00884838054202(21)364, (01)00884838054202(21)982, (01)00884838054202(21)634, (01)00884838059115(21)124, (01)00884838054202(21)190, (01)00884838054202(21)818, (01)00884838054202(21)1394, (01)00884838054202(21)1396, (01)00884838054202(21)1646, (01)00884838054202(21)386, (01)00884838054226(21)119, (01)00884838054226(21)126, (01)00884838054202(21)1650, (01)00884838054189(21)543, (01)00884838054202(21)2275, (01)00884838054189(21)1248, (01)00884838054202(21)1058, (01)00884838054189(21)561, (01)00884838059115(21)274, (01)00884838054202(21)1353, (01)00884838054202(21)1466, (01)00884838054196(21)319, (01)00884838…
- UPC codes
- 00884838054202, 00884838059115, 00884838054189, 00884838054196, 00884838054226, 00884838054219
Products covered by this recall
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Check your product
The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00884838054202
- 00884838059115
- 00884838054189
- 00884838054196
- 00884838054226
- 00884838054219
Model or item number
On the rating label, the box or the instruction sheet.
- 722026
- 722027
- 722028
- 722029
- 722035
- 722038
- 722
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Philips Medical Systems Nederland B.v. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Veenpluis 6, Best
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Philips Medical Systems Nederland B.v. medical devices recalled?
Firmware issue potentially leading to loss of geometry movements. Firmware issue potentially leading to loss of geometry movements.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00884838054202, 00884838059115, 00884838054189; model number 722026, 722027, 722028. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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