TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
FDA Recall Z-1767-2020 · Posted 2020-04-23
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Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2020-03-05
Date Terminated2021-02-11
Product Quantity81,626
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.
Firm 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 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
Distribution Pattern
The products were distributed US nationwide. Global distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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