Philips Azurion X-Ray System Cable Hose Carriers May Loosen or Break
Bolts and plastic parts of cable hose carriers on Philips Azurion X-ray systems may loosen or break during monitor movement or rotation, potentially causing the cable hose to become unsecured.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The hazard is structural deterioration of fasteners and mounting components, and the source text explicitly does not report any injuries or illnesses. The hazard is potential/theoretical in nature.
Plain-English summary
Philips Azurion X-ray systems are being recalled because the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time. This deterioration can occur due to the forces applied when the monitor is moved or rotated.
Affected systems include multiple Azurion models: Azurion 3 (M12 and M15), Azurion 5 (standard, M12, and M20), Azurion 7 (standard, B12, B20, M12, and M20). A total of 1,718 units have been distributed worldwide, including to the United States and Canada.
Customers who operate these systems should inspect the cable hose carriers for any signs of loosening, cracking, or breakage. If damage is detected, they should contact Philips Medical Systems for service or replacement parts. Philips has issued this Class II recall to prevent potential safety risks associated with cable hose displacement.
The recalled product
- Product
- Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- cable-hose-failure
- fastener-deterioration
- structural-integrity
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)
- (01)00884838099203(21)178
- (01)00884838099203(21)93]
- 722229 [(01)00884838116726(21)22
- (01)00884838116726(21)9
- (01)00884838116726(21)16
- (01)00884838116726(21)15
- (01)00884838116726(21)5
- (01)00884838116726(21)3
- (01)00884838116726(21)4
- (01)00884838116726(21)6
- (01)00884838116726(21)2
- (01)00884838099210(21)328
- (01)00884838099210(21)389
- (01)00884838099210(21)378
- (01)00884838099210(21)243
- (01)00884838099210(21)392
- (01)00884838099210(21)396
- (01)00884838099210(21)13
- (01)00884838099210(21)379
- (01)00884838099210(21)385
Distribution
Distributed nationwide across the United States.