FDA Device Recall Z-0007-2025: Philips North America

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-2025.

Recall Res Number

Z-0007-2025

Recalling Firm / Manufacturer

Philips North America

FEI Number

3006648320

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-01-18

Date Posted

2024-10-01

Date Terminated

N/A

Product Code

DSI

Event Number

95301

Product Quantity

8,449 devices

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.

Action Details An IMPORTANT PRODUCT NOTICE dated 1/18/23 was sent to customers. The actions planned by Philips to correct the problem A Philips representative will reach out to you to arrange a replacement of the sample gas pump. Affected products and how to identify them Affected product is the 866173 lntelliVue G7m Anesthesia Gas Module. Both the product number and the serial number on the G7m product is contained on the back of the product, preceded by "REF" and "SN", respectively. If you need any further information or support concerning this issue, please contact your local Philips representative.

Distribution Pattern US Nationwide. Global Distribution.

Code Information / Serial Numbers UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627

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Medical Device Recall: Z-0007-2025

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer