FDA recall Z-2547-2019

Philips North America, LLC · Class II · device

Product

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2019-08-23
Report date
2019-09-25
Termination date
2024-01-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2547-2019