TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Recall
- Recall Number
- Z-1767-2020
- Event Number
- 85241
- Firm
- Philips North America, LLC
- FEI Number
- 1218950
- Product Code
- MHX
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- March 5, 2020
- Posted
- April 23, 2020
- Terminated
- February 11, 2021
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
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.
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
The products were distributed US nationwide. Global distribution.
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