Philips Azurion X-ray System Software Issue Causes Restart and Imaging Loss
Philips Azurion interventional x-ray systems may continuously restart due to a software issue, causing loss of imaging functionality and data. If this occurs during a procedure, the procedure may be delayed or aborted.
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: Class II medical device recall of critical imaging system with confirmed functional defect (software-caused continuous restart) resulting in loss of imaging capability and data. Poses risk to procedure outcomes during clinical use. No illnesses, injuries, or hospitalizations reported to date.
Plain-English summary
Philips is recalling Azurion interventional fluoroscopic x-ray systems due to a software issue affecting multiple model variants. The systems are used in medical facilities to provide real-time imaging during interventional procedures.
A software issue can cause these systems to continuously restart. When this occurs, the system loses imaging functionality and data. If a restart happens during a medical procedure, it may delay or abort the ongoing procedure.
The FDA has classified this as a Class II recall. Approximately 1,799 units were distributed in the U.S., with an additional 5,747 distributed internationally. Healthcare facilities with affected Philips Azurion systems should contact Philips Medical Systems for information on corrective measures.
The recalled product
- Product
- Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- imaging-loss
- data-loss
- system-restart
- procedure-interruption
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)
- System Product Name - UDI-DI Azurion 3M12 - 00884838085275
- 00884838099203
- 00884838101890
- Azurion 3M15 - 00884838085282
- 00884838099210
- Azurion 5M12 - 00884838099227
- Azurion 5M20 - 00884838099234
- Azurion 7B12/12 - 00884838059290
- 00884838064775
- 00884838085350
- 00884838099265
- Azurion 7B20/15 - 00884838059207
- 00884838085367
- 00884838099272
- 00884838101883
- Azurion 7M12 - 00884838085251
- 00884838099241
- Azurion 7M20 - 00884838059184
- 00884838059191
- 00884838059207
Distribution
Distributed nationwide across the United States.
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