RecallRadar

FDA Device recall Z-0559-2024

Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion…

On 2023-12-27 the FDA classified a Class II recall of Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion… by Philips Medical Systems Nederland B V, citing 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 li….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0559-2024
ClassificationClass II
Statusongoing
Initiated2023-11-03
Published2023-12-27
Last updated2026-09-13 11:56 UTC
CompanyPhilips Medical Systems Nederland B V
DistributionUS

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

Reason

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

Identifiers

code_info
Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21); 722079 Azurion 7 M20 (01)00884838085268(21); 72…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).

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0559-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.