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Philips Azurion System HDD
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MEDICAL DEVICE RECALLMODERATE

Philips Azurion System HDD

Philips recalls Azurion systems over aging HDDs that may cause loss of imaging or movement.

What to do

Contact Philips Medical Systems for a free replacement of the affected HDD. Do not attempt to replace the HDD yourself; a Philips service representative will perform the replacement.

Recalled
Listed
Updated
Recall No.
Z-2258-2026
Agency
FDA
Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall ID
98826
Status
ONGOING

Recall at a glance

Quantity recalled
3069 units (872 US, 2224 OUS)

Why it was recalled

Philips is recalling certain Azurion systems because the hard disk drives (HDDs) in the system PCs may degrade with age, particularly after six years of service, potentially causing loss of imaging functionality, and in Allura systems, loss of motorized movement or data. A system restart may temporarily restore function.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).Z-2258-202600884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), 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),Z-2259-202600884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), 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);–00884838059030, 1123, 932, 239, 360, 500, 794, 939, 921, 286, 1440, 1144, 521, 107, 1025, 668, 656, 1261, 1170, 585, 1128, 882, 1230, 280, 488, 787, 968, 890, 780, 190, 1181, 694, 1279, 344, 1149, 423, 1176, 1173, 1040, 1309 (+2749 more, see the official notice)

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification