Reported Dec 27, 2023 · Ongoing
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Philips Azurion systems
- with monoplane fixed ceiling mounts722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
- Lot codes and dates
- 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)
- Mdoel/Product Name/UDI-DI
- Amount recalled
- 3821 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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