Recall Z-2175-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
| Date | May 4, 2017 |
| Status | Terminated |
| Reason | Manufacturing defect may cause localized heating, which may result in localized skin burn. |
| Root cause | Device Design |
| Action | On May 4, 2017, Philips sent a field safety notice to their consignees. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue: Philips will exchange affected NMT Patient cables at the customer site. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Immediately identify all affected cables, remove them from inventory and hold them for exchange by a Philips Healthc |
| Quantity | 9120 devices |
| Distribution | US: AK AZ CA CO FL HI IA IL IN KY MA MD MI MN MO MS NC NE NH NJ NM NV NY OH OR PA TX VA WA WI WV OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Canada Chile China Colombia Costa Rica Denmark Dominican Rep Egypt Finlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122439 | INTELLIVUE PATIENT MONITOR Philips Medizin Systeme Boeblingen GmbH, Aug 29, 2012 |