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Open, Classified

IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

FDA Recall Z-2689-2020 · Posted None

Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2020-06-25
Product Quantity3075

Reason for Recall

The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.

Firm Action

On 6/25/2020, the firm distributed Customer Information Medical Device Correction letters to affected customers. Customers were informed that the current firmware on the 866173 G7m Gas Module needed to be updated in order to correct an issue which was causing the device to erroneously detect a premature failure of the pump. When the error occurs, the device will cease measurement and display of gas levels, and generate one or more technical or INOP alarms. Customers were instructed to ensure their staff is informed of the actions to be taken for INOP alarms, as can be found in the Instructions for Use. Local Philips Service representatives will contact customers and will update the firmware on affected devices. If you have further questions or concerns about the issue, please contact your local Philips representative or Philips Customer Support at 1-800-722-9377.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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