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U.S. Department of Health and Human Services

Class 2 Device Recall TRx4851A 2.4 GHz IntelliVue TRX

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  Class 2 Device Recall TRx4851A 2.4 GHz IntelliVue TRX see related information
Date Initiated by Firm March 05, 2020
Date Posted April 23, 2020
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-1766-2020
Recall Event ID 85241
510(K)Number K041741  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
Code Information Serial Numbers: 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Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer 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.
FDA Determined
Cause 2		 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 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
Quantity in Commerce 21,672
Distribution The products were distributed US nationwide. Global distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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