Recall Z-0007-2025— Philips North America

Name: FDA recall Z-0007-2025
Creator: U.S. Food and Drug Administration
Published: 2023-01-18

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-01-18. It names one FDA 510(k) clearance: K151681. Product: IntelliVue G7m Anesthesia Gas Module, Product Number 866173. Reason: The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2023-01-18
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K151681 — IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH·cleared 2015-07-17

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

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

Reason for recall

The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.

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