Philips Azurion X-ray imaging systems affected by software communication defect
A software communication issue in Philips Azurion X-ray imaging systems can cause loss of imaging functionality during use, potentially delaying critical treatment for emergency patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Medical device with a confirmed software defect causing loss of critical imaging functionality. While the potential consequences are serious, including death in emergency situations, no illnesses or injuries have been reported. Classified as FDA Class II.
Plain-English summary
Philips is recalling Azurion R1.x and R2.x X-ray imaging systems worldwide due to a software issue that affects the internal communication between system software and X-ray generator firmware. The recall involves 9,707 units total, with 2,300 units in the United States.
The software issue can cause loss of imaging (X-ray) functionality, which could result in a delay of therapy. This delay is particularly dangerous for patients undergoing urgent interventions for life-threatening conditions such as acute ischemic stroke, ST-segment elevation myocardial infarction, or life-threatening bleeding. In these situations, inability to obtain X-ray images could lead to serious adverse health outcomes, including the possibility of death.
Affected healthcare facilities should contact Philips for information about software updates or corrective actions. Consult the FDA Medical Device Recalls database for additional details about this recall.
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-defect
- imaging-loss
- therapy-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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