Azurion R1.x and R2.x X-ray systems software communication issue
Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is FDA Class II, and the source text explicitly identifies potential for serious adverse health outcomes including death, especially in patients with urgent or life-threatening conditions. This meets the criterion for "Severe" classification under the rubric.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Azurion R1.x and R2.x systems with model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722281, and 722282 (all software versions). The systems are used for X-ray imaging in medical facilities.
A software issue has been identified in the internal communication process between the system software and the X-ray generator firmware. This issue can cause loss of imaging (X-ray) functionality, which may result in a delay of therapy.
A delay in therapy 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 such as acute ischemic stroke, ST-segment elevation myocardial ischemia, or life-threatening bleeding.
The recall affects approximately 9,707 units worldwide, including 2,300 units in the United States. Healthcare facilities using these systems should contact Philips Medical Systems for guidance on remediation and next steps.
The recalled product
- Product
- 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 Version: Al
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- software-malfunction
- imaging-failure
- treatment-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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