Reported Sep 10, 2025 · Ongoing

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding…

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 4-6 · Best, N/A · N/A

Is this the product you have?

16 of 16 products

Products covered by this recall
Model / number	Product as published
`722003.`	Allura Xper FD10
`722005.`	Allura Xper FD10/10
`722006.`	Allura Xper FD20
`722008.`	Allura Xper FD20 Biplane
`722010.`	Allura Xper FD10
`722011.`	Allura Xper FD10/10
`722012.`	Allura Xper FD20
`722013.`	Allura Xper FD20 Biplane
`722023.`	Allura Xper FD20 OR Table
`722026.`	Allura Xper FD10
`722027.`	Allura Xper FD10/10
`722028.`	Allura Xper FD20
`722029.`	Allura Xper FD20/10
`722035.`	Allura Xper FD20 OR Table
`722038.`	Allura Xper FD20/20
`722058.`	Allura Xper FD20/15, 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.

Lot codes and dates: 16 of 16 products
Products covered by this recall
# Barcodes Product as published
1 Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 292, 314, 1077
2 2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI)
3 3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 2126, 2200, 1560, 1921, 1724, 1219.
4 Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 516, 142, 434, 418
5 00884838059030 5. Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 33, 968, 763, 215, 1425, 1126, 818, 1028, 1043, 608, 907, 50, 1390, 706, 900, 1439, 1152, 165, 62, 1031, 1088, 741, 840
6 00884838059047 6. Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308, 344, 243, 266, 231, 286, 369, 378, 259
7 00884838059054 7. Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 2898, 2896, 1594, 1249, 2057, 2135, 2857, 792, 2841, 1334, 1550, 2868, 2912, 1094, 2282, 1681, 1332, 2032, 2076, 176, 835, 626, 1320, 1439, 1667.
8 00884838059061 Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 115, 575, 272, 632, 378, 608, 412, 353, 595, 355
9 00884838059085 9. Model Number/System Code (UDI); Serial Numbers: 722023 (00884838059085); 128, 83, 86, 134
10 00884838054189 10. Model Number/System Code (UDI); Serial Numbers: 722026 (00884838054189); 233, 561, 942, 368, 826, 1115, 539, 159, 598, 365, 528, 603, 263, 792, 783, 679, 680, 406, 388, 302, 659, 736, 1022, 22, 506, 120
11 00884838054196 11. Model Number/System Code (UDI); Serial Numbers: 722027 (00884838054196); 106, 127, 78, 204, 113, 82, 66
12 00884838054202 12. Model Number/System Code (UDI); Serial Numbers: 722028 (00884838054202); 668, 265, 1154, 180, 880, 274, 172, 1111, 806, 451, 236, 887, 874, 1266, 1499, 1514, 1457, 908, 1292, 247, 944, 951, 1390, 1662, 415, 105, 1675, 348, 1562, 1029, 51, 941, 403, 427, 659, 935, 1225, 1165, 1621, 725, 723, 1559, 753
13 00884838054219 13. Model Number/System Code (UDI); Serial Numbers: 722029 (00884838054219); 69
14 00884838054240 14. Model Number/System Code (UDI); Serial Numbers: 722035 (00884838054240); 187, 125, 40, 108, 163, 26, 75, 173, 190
15 00884838054226 15. Model Number/System Code (UDI); Serial Numbers: 722038 (00884838054226)
16 00884838059115 16. Model Number/System Code (UDI); Serial Numbers: 722058 (00884838059115); 238, 161, 84, 39, 133, 244, 193, 187, 102.
Amount recalled: 192 untis

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Nationwide
AL
AZ
CA
DC
FL
GA
HI
ID
IL
KS
KY
LA
MI
MN
MO
NC
NJ
NM
NV
NY
OH
OR
PA
TN
TX
UT
VA
WI
WV

Why it was recalled

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

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 systems not configured with an optional auxiliary pan handle. Includes… May 27, 2026

45 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1		Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 292, 314, 1077
2		2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI)
3		3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 2126, 2200, 1560, 1921, 1724, 1219.
4		Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 516, 142, 434, 418
5	`00884838059030`	5. Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 33, 968, 763, 215, 1425, 1126, 818, 1028, 1043, 608, 907, 50, 1390, 706, 900, 1439, 1152, 165, 62, 1031, 1088, 741, 840
6	`00884838059047`	6. Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308, 344, 243, 266, 231, 286, 369, 378, 259
7	`00884838059054`	7. Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 2898, 2896, 1594, 1249, 2057, 2135, 2857, 792, 2841, 1334, 1550, 2868, 2912, 1094, 2282, 1681, 1332, 2032, 2076, 176, 835, 626, 1320, 1439, 1667.
8	`00884838059061`	Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 115, 575, 272, 632, 378, 608, 412, 353, 595, 355
9	`00884838059085`	9. Model Number/System Code (UDI); Serial Numbers: 722023 (00884838059085); 128, 83, 86, 134
10	`00884838054189`	10. Model Number/System Code (UDI); Serial Numbers: 722026 (00884838054189); 233, 561, 942, 368, 826, 1115, 539, 159, 598, 365, 528, 603, 263, 792, 783, 679, 680, 406, 388, 302, 659, 736, 1022, 22, 506, 120
11	`00884838054196`	11. Model Number/System Code (UDI); Serial Numbers: 722027 (00884838054196); 106, 127, 78, 204, 113, 82, 66
12	`00884838054202`	12. Model Number/System Code (UDI); Serial Numbers: 722028 (00884838054202); 668, 265, 1154, 180, 880, 274, 172, 1111, 806, 451, 236, 887, 874, 1266, 1499, 1514, 1457, 908, 1292, 247, 944, 951, 1390, 1662, 415, 105, 1675, 348, 1562, 1029, 51, 941, 403, 427, 659, 935, 1225, 1165, 1621, 725, 723, 1559, 753
13	`00884838054219`	13. Model Number/System Code (UDI); Serial Numbers: 722029 (00884838054219); 69
14	`00884838054240`	14. Model Number/System Code (UDI); Serial Numbers: 722035 (00884838054240); 187, 125, 40, 108, 163, 26, 75, 173, 190
15	`00884838054226`	15. Model Number/System Code (UDI); Serial Numbers: 722038 (00884838054226)
16	`00884838059115`	16. Model Number/System Code (UDI); Serial Numbers: 722058 (00884838059115); 238, 161, 84, 39, 133, 244, 193, 187, 102.