Recall Z-2531-2020 ยท DSI Detector And Alarm, Arrhythmia
Philips North America, LLC
Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)
| Date | Jun 8, 2020 |
| Status | Terminated |
| Reason | Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor. |
| Root cause | Device Design |
| Action | Philips issued Customer Information Medical Device Correction (CIL86201894B) via priority mail on 6/8/20. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: To check if this issue affects your M3015A, compare the serial number of your device with the affected serial numbers identified; Use affected M3015A extensions only together with an lntelliVue X2 or MMS.; Do not combine an affected M3015A with an lntelliVue X3 or MMX; Philips Healthcare is distributing with this letter an addendum |
| Quantity | 46,597 Units WW |
| Distribution | Nationwide Foreign: Angola Angola Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana Germany Ghana Gibraltar Greece Greenland Guadeloupe Guatemala Hong Kon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B Hewlett-Packard GmbH, Feb 3, 2000 |