[pending] Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Pending LLM rewrite. Source: FDA_DEVICE Z-1674-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
The recalled product
- Product
- Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Devices
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)
- (1) System Code: 722064
- UDI: 00884838085282
- System Serial Number: 209
- 238
- 201
- 258
- 260
- 261
- 314
- 229
- 291
- 270
- 267
- 218
- 335
- 513
- 61
- 161
- 162
- 169
Distribution
Distributed nationwide across the United States.
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