TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 45356400728

FDA device recall Z-1767-2020 · posted 2020-04-23 · Terminated

Recall details

Recalling firm

Philips North America, LLC

Reason for recall

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.

Action taken

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 the form. Philips will contact you should further action be necessary. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800-722-9377

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

81,626

Distribution

The products were distributed US nationwide. Global distribution.

Date initiated

2020-03-05

Date posted

2020-04-23

Date terminated

2021-02-11

Location

Andover, MA

Related 510(k) clearances