Reported Jun 18, 2025 · Ongoing
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079,…
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
Is this the product you have?
- Azurion R1.x and R2.x systems
- Model Numbers
(1) 722063(2) 722064(3) 722067(4) 722068(5) 722078(6) 722079(7) 722221(8) 722222(9) 722223(10) 722224(11) 722225(12) 722226(13) 722227(14) 722228(15) 722280(16) 722281(17) 722282
- Software VersionAll software versions
- Lot codes and dates
- Model Numbers
(1) 722063(2) 722064(3) 722067(4) 722068(5) 722078(6) 722079(7) 722221(8) 722222(9) 722223(10) 722224(11) 722225(12) 722226(13) 722227(14) 722228(15) 722280(16) 722281(17) 722282
- UDI-DIs
(1) 00884838085275(2) 00884838085282(3) 00884838085350(4) 00884838085367(5) 00884838085251(6) 00884838085268(7) 00884838099203(8) 00884838099210(9) 00884838099241(10) 00884838099258(11) 00884838099265(12) 00884838099272(13) 00884838099227(14) 00884838099234(15) Not commercialized in the US(16) Not commercialized in the US(17) Not commercialized in the US
- Model Numbers
- Amount recalled
- 9,707 units (2300 US, 7407 OUS)
Where it was sold
- Nationwide
Why it was recalled
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
This product could cause temporary or reversible health problems — stop using it.
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