Recall Z-1766-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America, LLC
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
| Date | Apr 23, 2020 (initiated Mar 5, 2020) |
| Status | Terminated |
| Reason | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs, the Information Center will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alarms. |
| Root cause | Software design |
| Action | Urgent - Medical Device Recall notification letters dated 3/5/20 were sent to customers. " Confirm whether PIC iX Release C.02.xx and C.03.01 is used anywhere in your facility, and if so: o Identify Philips TRx4841A and TRx4851A Telemetry Transceivers in your facility by using the instructions provide in the HOW TO IDENTIFY AFFECTED PRODUCTS section above. o Immediately discontinue use of the Philips TRx4841A and TRx4851A Telemetry Transceiver. Philips support for these devices ended in 2017. " Complete, sign and return the reply form provided on the last page of this letter, as directed on |
| Quantity | 21,672 |
| Distribution | The products were distributed US nationwide. Global distribution. |
| 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 |