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MEDICAL DEVICE RECALLMODERATE

Philips Azurion 5 M20 and 7 M12 Systems

Philips recalls Azurion 5 M20 and 7 M12 systems over risk of unexpected table movement when Reset Geometry is pressed.

What to do

Contact Philips Medical Systems immediately to schedule a software update. Do not use the Reset Geometry button until the update is applied.

Recalled
Listed
Updated
Recall No.
Z-1348-2026
Agency
FDA
Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall ID
98326
Status
ONGOING

Why it was recalled

Philips Medical Systems is recalling Azurion 5 M20 (model numbers 722228, 722232, 722281) and Azurion 7 M12 (model numbers 722078, 722223, 722233) imaging systems with software versions R1.X, R2.X, or R3.X. Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed, even when a table lock is active.

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 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.XZ-1348-2026884838085251, 884838099241, 884838116764
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.XZ-1346-2026884838085350, 884838099265, 884838116788
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.XZ-1349-2026884838085268, 884838099258, 884838116771
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.XZ-1350-2026884838099227, 884838099258, 884838116740
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.XZ-1344-2026884838085275, 884838099203, 884838116726
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.XZ-1351-2026884838099234, 884838116757
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.XZ-1347-2026884838085367, 884838099272, 884838116801
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.XZ-1345-2026884838085282, 884838099210, 884838116733

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 →

Other recent recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Editorial summary by Recall Canary · summary updated 2026-07-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification