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IntelliVue G7m Anesthesia Gas Module, Product Number 866173 recallZ-0007-2025 · Philips North America · initiated Jan 18, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0007-2025
Status
Open, Classified
Initiated by the company
Jan 18, 2023
Posted by the FDA
Oct 1, 2024
Recalling firm
Philips North America
Quantity
8,449 devices
Product code
DSI
FDA submissions
K151681
Distribution
US Nationwide. Global Distribution.

Product description

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

Code information (models, lots, serial numbers)

UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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