Recall Z-2547-2019 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America, LLC
IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping syste
| Date | Aug 23, 2019 |
| Status | Terminated |
| Reason | Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations |
| Root cause | Process control |
| Action | Philips issued customer notification on 08/19/2019 and delivering on 08/23/2019 via priority mail. Letter states reason for recall, health risk and action to take: Customers with affected cables installed need not take any immediate action. The cables subject to this recall do not affect the normal operation of MX4O System with Smart Hopping Infrastructure. Philips Healthcare will contact you to schedule a service team to replace affected cables. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support |
| Quantity | 1790 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041741 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN Philips Medical Systems, Inc., Jul 21, 2004 |