Class II U.S. Food and Drug Administration

Philips Medical Systems Nederland B.v. Allura system recall: The deaeration hose in X-ray tube cooling units type CU3101

Recall published 5 months ago

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

The hazard: Potency, impurity or stability failure

The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

What the notice says: The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2228-2026
Published
May 27, 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
3314 units (816 US, 2498 OUS)
Distribution
Nationwide
Made in
Netherlands
Lot / code info
Code Information: Allura: 1. Allura Xper FD10C; Model: 722001; UDI-DI: N/A; Serial Numbers: 170, 242, 267, 142, 206, 316, 9, 306, 103, 33, 220; 2. Allura Xper FD10F; Model: 722002; UDI-DI: N/A; Serial Numbers: 0, 81, 47; 3. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 208, 392, 109, 45, 1953, 1471, 1551, 485, 152, 928, 501, 90, 1435, 81, 939, 160, 472, 1349, 439, 1958, 1525, 72, 1187, 912, 368, 328A, 37, 1286, 1223, 487, 1061, 833, 688, 317, 157, 639, 375, 420, 225, 1338, 614, 214, 230, 736, 64, 1090, 1094, 1932, 1531, 421, 984, 373, 313, 918, 602, 374, 750, 1934, 1751, 1661, 961, 791, 454, 868, 416, 1329, 241; 4. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)921, (01)00884838059030(21)1440, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1428, (01)00884838059030(21)1396, (01)00884838059030(21)298, (01)00884838059030(21)1432, (01)00884838059030(21)1425, (01)00884838059030(21)1398, (01)00884838059030(21)1397, (01)00884838059030(21)1391, (01)00884838059030(21)1395, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)946, (01)00884838059030(21)1424, (01)00884838059030(21)1244, (01)00884838059030(21)1122, (01)00884838059030(21)1198, (01)00884838059030(21)1421, (01)00884838059030(21)1423, (01)00884838059030(21)1438, (01)00884838059030(21)697, (01)00884838059030(21)1192, (01)00884838059030(21)1326, (01)00884838059030(21)402, (01)00884838059030(21)1148, (01)00884838059030(21)1439, (01)00884838059030(21)1431, (01)00884838059030(21)1404, (01)00884838059030(21)1140, (01)00884838059030(21)1429, (01)00884838059030(21)1430, (01)00884838059030(21)1403, (01)00884838059030(21)1393, (01)00884838059030(21)1402, (01)00884838059030(21)406, (01)00884838059030(21)71, (01)00884838059030(21)1434, (01)00884838059030(21)1392, (01)00884838059030(21)1379, (01)00884838059030(21)1401, (01)00884838059030(21)1197, (01)00884838059030(21)1435, (01)00884838059030(21)1346, (01)00884838059030(21)232, (01)00884838059030(21)231, (01)00884838059030(21)248, (01)00884838059030(21)1137, (01)00884838059030(21)1446, (01)00884838059030(21)1422, (01)00884838059030(21)1433, (01)00884838059030(21)1131, (01)00884838059030(21)1218; 5. Allura Xper FD10; Model: 722026; UDI: (01)00884838054189(21)683, (01)00884838054189(21)1052, (01)00884838054189(21)1051, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)1072, (01)00884838054189(21)796, (01)00884838054189(21)1248, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)969, (01)00884838054189(21)1246, (01)00884838054189(21)877, (01)00884838054189(21)843, (01)00884838054189(21)1231, (01)00884838054189(21)1038, (01)00884838054189(21)1287, (01)00884838054189(21)878, (01)00884838054189(21)558, (01)00884838054189(21)633, (01)00884838054189(21)1050, (01)00884838054189(21)1000, (01)00884838054189(21)909, (01)00884838054189(21)841, (01)00884838054189(21)713, (01)00884838054189(21)731, (01)00884838054189(21)646, (01)00884838054189(21)728, (01)00884838054189(21)765, (01)00884838054189(21)959, (01)00884838054189(21)825, (01)00884838054189(21)942, (01)00884838054189(21)1192, (01)00884838054189(21)990, (01)00884838054189(21)774, (01)00884838054189(21)648, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054189(21)627, (01)00884838054189(21)604, (01)00884838054189(21)716, (01)00884838054189(21)1182, (01)00884838054189(21)965, (01)00884838054189(21)1189, (01)00884838054189(21)1126, (01)00884838054189(21)1210, (01)00884838054189(21)1239, (01)00884838054189(21)1215, (01)00884838054189(21)696, (01)00884838054189(21)664, (01)00884838054189(21)845, (01)00884838054189(21)778, (01)00884838054189(21)935, (01)00884838054189(21)782, (01)00884838054189(21)694, (01)00884838054189(21)838, (01)00884838054189(21)973, (0…
UPC codes
00884838059030, 00884838054189

Products covered by this recall

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

Check your product

The notice names 25 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.

  • 00884838059030
  • 00884838054189

Model or item number

On the rating label, the box or the instruction sheet.

  • 722001
  • 722002
  • 722003
  • 722010
  • 722026

Serial number

On the rating plate, often next to the date of manufacture.

  • 170
  • 242
  • 267
  • 142
  • 206
  • 316
  • 306
  • 103
  • 81
  • 47
  • 208
  • 392
  • 109
  • 45
  • 1953
  • 1471
  • 1551
  • 485

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 Potency

Philips Medical Systems Nederland B.v. — The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  3. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  4. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

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?

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838059030, 00884838054189; model number 722001, 722002, 722003. 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?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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