Official recall record
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 an
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-07-16
- Country of alert
- Netherlands
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00884838116757
- Brand on record
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
What the authority reported
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Other recalls from this brand
- 2026-07-16 · US FDA — Medical Devices
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223 - 2026-04-30 · US FDA — Medical Devices
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064
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