Reported May 27, 2026 · Ongoing

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura…

Philips Medical Systems Nederland B.v.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 6 · Best · N/A

Is this the product you have?

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)

Lot codes and dates: Code InformationAllura: 1. Allura Xper FD10C
Model722001
UDI-DIN/A
Serial Numbers
170
242
267
142
206
316
9
306
103
33
220
2. Allura Xper FD10F
Model722002
UDI-DIN/A
Serial Numbers
0
81
47
3. Allura Xper FD10
Model722003
UDI-DIN/A
Serial Numbers
68 of 68 codes
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
Model722010
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
Model722026
UDI
587 of 587 codes
(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
Model722005
UDI-DIN/A:
Serial Numbers
51
22
259
196
530
435
233
309
89
29
399
480
6
41
71
124
458
54
55
528
80
556
74
203
60
125
426
123
64
299
7. Allura Xper FD10/10
Model722011
UDI
(01)00884838059047(21)49
(01)00884838059047(21)196
(01)00884838059047(21)157
(01)00884838059047(21)82
(01)00884838059047(21)83
(01)00884838059047(21)275
(01)00884838059047(21)101
(01)00884838059047(21)347
(01)00884838059047(21)198
(01)00884838059047(21)94
(01)00884838059047(21)176
(01)00884838059047(21)329
(01)00884838059047(21)337
8. Allura Xper FD10/10
Model722027
UDI
155 of 155 codes
(01)00884838054196(21)351
(01)00884838054196(21)332
(01)00884838054196(21)71
(01)00884838054196(21)240
(01)00884838054196(21)241
(01)00884838054196(21)298
(01)00884838054196(21)175
(01)00884838054196(21)280
(01)00884838054196(21)222
(01)00884838054196(21)183
(01)00884838054196(21)202
(01)00884838054196(21)164
(01)00884838054196(21)335
(01)00884838054196(21)288
(01)00884838054196(21)342
(01)00884838054196(21)306
(01)00884838054196(21)307
(01)00884838054196(21)265
(01)00884838054196(21)169
(01)00884838054196(21)203
(01)00884838054196(21)234
(01)00884838054196(21)267
(01)00884838054196(21)209
(01)00884838054196(21)284
(01)00884838054196(21)263
(01)00884838054196(21)174
(01)00884838054196(21)305
(01)00884838054196(21)246
(01)00884838054196(21)255
(01)00884838054196(21)178
(01)00884838054196(21)266
(01)00884838054196(21)187
(01)00884838054196(21)321
(01)00884838054196(21)328
(01)00884838054196(21)282
(01)00884838054196(21)184
(01)00884838054196(21)337
(01)00884838054196(21)357
(01)00884838054196(21)213
(01)00884838054196(21)293
(01)00884838054196(21)292
(01)00884838054196(21)346
(01)00884838054196(21)211
(01)00884838054196(21)144
(01)00884838054196(21)238
(01)00884838054196(21)247
(01)00884838054196(21)347
(01)00884838054196(21)188
(01)00884838054196(21)196
(01)00884838054196(21)339
(01)00884838054196(21)343
(01)00884838054196(21)256
(01)00884838054196(21)338
(01)00884838054196(21)334
(01)00884838054196(21)294
(01)00884838054196(21)345
(01)00884838054196(21)172
(01)00884838054196(21)323
(01)00884838054196(21)324
(01)00884838054196(21)189
Model722006
UDI-DIN/A
Serial Numbers
146 of 146 codes
2051
1936
518
326
66
2587
332
249
2274
1496
2183
579
1044
2336
443
1913
1259
79
939
283
405
2161
2068
560
1747
1601
479
970
1586
878
2537
658
384
1469
588
328
235
381
1536
2504
103
826
962
169
1197
223
595
934
1364
972
2567
2042
2380
828
528
288
1889
1578
1000
942
Model722012
UDI
258 of 258 codes
(01)00884838059054(21)2942
(01)00884838059054(21)2265
(01)00884838059054(21)2735
(01)00884838059054(21)2707
(01)00884838059054(21)135
(01)00884838059054(21)2740
(01)00884838059054(21)2843
(01)00884838059054(21)2835
(01)00884838059054(21)760
(01)00884838059054(21)735
(01)00884838059054(21)174
(01)00884838059054(21)2855
(01)00884838059054(21)2856
(01)00884838059054(21)2712
(01)00884838059054(21)606
(01)00884838059054(21)2721
(01)00884838059054(21)2085
(01)00884838059054(21)695
(01)00884838059054(21)2202
(01)00884838059054(21)2828
(01)00884838059054(21)601
(01)00884838059054(21)1207
(01)00884838059054(21)2898
(01)00884838059054(21)334
(01)00884838059054(21)1656
(01)00884838059054(21)483
(01)00884838059054(21)2305
(01)00884838059054(21)2896
(01)00884838059054(21)2726
(01)00884838059054(21)2722
(01)00884838059054(21)451
(01)00884838059054(21)2883
(01)00884838059054(21)2755
(01)00884838059054(21)2741
(01)00884838059054(21)1301
(01)00884838059054(21)2736
(01)00884838059054(21)782
(01)00884838059054(21)2890
(01)00884838059054(21)2829
(01)00884838059054(21)1675
(01)00884838059054(21)412
(01)00884838059054(21)320
(01)00884838059054(21)1224
(01)00884838059054(21)453
(01)00884838059054(21)1964
(01)00884838059054(21)325
(01)00884838059054(21)2742
(01)00884838059054(21)2889
(01)00884838059054(21)2713
(01)00884838059054(21)2899
(01)00884838059054(21)1272
(01)00884838059054(21)2857
(01)00884838059054(21)2886
(01)00884838059054(21)100
(01)00884838059054(21)2875
(01)00884838059054(21)2888
(01)00884838059054(21)71
(01)00884838059054(21)1807
(01)00884838059054(21)418
(01)00884838059054(21)1329
Model722028
UDI
(01)00884838054202(21)1756
(01)00884838054202(21)1569
(01)00884838054202(21)1956
(01)00884838054202(21)2206
(01)00884838054202(21)1233
(01)00884838054202(21)928
(01)00884838054202(21)2502
(01)00884838054202(21)1774
(01)00884838054202(21)869
(01)00884838054202(21)1017
(01)00884838054202(21)1957
(01)00884838054202(21)2261
(01)00884838054202(21)866
(01)00884838054202(21)1310
(01)00884838054202(21)1043
(01)00884838054202(21)1077
(01)00884838054202(21)995
(01)00884838054202(21)896
(01)00884838054202(21)877
(01)00884838054202(21)1439
(01)00884838054202(21)1343
(01)00884838054202(21)895
(01)00884838054202(21)1154
(01)00884838054202(21)1000
(01)00884838054202(21)1909
(01)00884838054202(21)1716
(01)00884838054202(21)1983
(01)00884838054202(21)2061
(01)00884838054202(21)1393
(01)00884838054202(21)1656
(01)00884838054202(21)1461
(01)00884838054202(21)1751
(01)00884838054202(21)1050
(01)00884838054202(21)1428
(01)00884838054202(21)1094
(01)00884838054202(21)2173
(01)00884838054202(21)1214
(01)00884838054202(21)52
(01)00884838054202(21)994
(01)00884838054202(21)1213
(01)00884838054202(21)1836
(01)00884838054202(21)982
(01)00884838054202(21)1646
(01)00884838054202(21)1396
(01)00884838054202(21)1394
(01)00884838054202(21)1650
(01)00884838054202(21)2275
(01)00884838054202(21)1058
(01)00884838054202(21)1353
Amount recalled: 3314 units (816 US, 2498 OUS)

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Nationwide
GA

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Philips Medical Systems Nederland B.v.

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039… Aug 19, 2026
Philips Allura under the following System Descriptions and corresponding model numbers… Aug 12, 2026
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for… Jun 24, 2026
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0… Jun 10, 2026
Azurion system Jun 3, 2026
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221… May 20, 2026

45 in total.

Where it was distributed

Georgia recalls

All recall categories · Browse the whole archive