Medical device manufacturer, Philips Healthcare, has issued a Customer Information Letter concerning HeartStart MRx monitor/defibrillator, models M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M4,M3536M5, M3536M6.
According to Philips, the HeartStart MRx instructions for use (IFU) have been improved to better clarify C02/EtC02 measurements taken by the MRx devices with software versions F.02, R.02, 9.xx or earlier versions. An addendum to the IFU has been issued.
According to the local supplier, the affected devices were distributed to Hong Kong. The Customer Information Letter and the IFU addendum will be sent to all affected customers.
If you are in possession of the products, please contact your supplier for necessary actions.