Recall Z-2689-2020— Philips North America, LLC
Class II · Ongoing
Class II FDA medical device recall by Philips North America, LLC, initiated 2020-06-25. It names one FDA 510(k) clearance: K151681. Product: IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173. Reason: 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..
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-06-25
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.