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Terminated

IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping system.

FDA Recall Z-2547-2019 · Posted None

Recall StatusTerminated
Product CodeMHX
Date Initiated2019-08-23
Date Terminated2024-01-03
Product Quantity1790 units

Reason for Recall

Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations

Firm Action

Philips issued customer notification on 08/19/2019 and delivering on 08/23/2019 via priority mail. Letter states reason for recall, health risk and action to take: Customers with affected cables installed need not take any immediate action. The cables subject to this recall do not affect the normal operation of MX4O System with Smart Hopping Infrastructure. Philips Healthcare will contact you to schedule a service team to replace affected cables. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800- SUPPORT 722-9377.

Root Cause

Process control

Distribution Pattern

Nationwide

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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