Recall Z-2689-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America, LLC
IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
| Date | Jun 25, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| 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 |
| Quantity | 3075 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151681 | IntelliVue Patient Monitor Philips Medizin Systeme Boeblingen GmbH, Jul 17, 2015 |