Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II medical device recall with a risk of harm from a falling component that could cause injury or compromise sterilization. No illnesses or injuries have been reported. The hazard is theoretical, based on potential collision scenarios, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Azurion systems with monoplane fixed ceiling mounts across six model numbers: 722078, 722079, 722223, 722224, 722227, and 722228. A total of 3,821 units have been distributed worldwide.
The ceiling-mounted L-arm contains a rotation cover that may become loose and fall if the L-arm collides with other hospital equipment, such as an operating light. This could potentially result in injury to staff or patients, or compromise the sterility of medical equipment.
These systems have been distributed to hospitals and medical facilities in the United States and over 100 countries worldwide.
Healthcare facilities using affected systems should contact Philips Medical Systems for guidance on inspection, repair, or replacement of the affected equipment.
The recalled product
- Product
- Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 3,821
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 (6)
- Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21)
- 722079 Azurion 7 M20 (01)00884838085268(21)
- 722223 Azurion 7 M12 (01)00884838099241(21)
- 722224 Azurion 7 M20 (01)00884838099258(21)
- 722227 Azurion 5 M12 (01)00884838099227(21)
- 722228 Azurion 5 M20 (01)00884838099234(21).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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