Recall Z-0559-2024— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-0559-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-03

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2023-11-03. It names one FDA 510(k) clearance: K200917. 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.

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-03
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.