Recall Z-2547-2019— Philips North America, LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America, LLC, initiated 2019-08-23, terminated 2024-01-03. It names one FDA 510(k) clearance: K041741. 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: Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations.
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-23
- Terminated
- 2024-01-03
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.