FDA-Device2017-06-07Class II

NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)

Philips Electronics North America Corporation
Hazard

Manufacturing defect may cause localized heating, which may result in localized skin burn.

Sold states
US: AK AZ CA CO FL HI IA IL IN KY MA MD MI MN MO MS NC NE NH NJ NM NV NY OH OR PA TX VA WA WI WV OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Canada Chile China Colombia Costa Rica Denmark Dominican Rep Egypt Finland France Germany Hong Kong Hungary Iceland India Indonesia Ireland Israel Italy Japan Latvia Lebanon Libya Lithuania Luxembourg Malaysia Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Peru Philippines Poland Portugal Qatar Romania Russia Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Ukraine United Kingdom Utd.Arab.Emir.
Affected count
9120 devices
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2175-2017

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