Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2175-2017 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMHX
Date Initiated2017-05-04
Date Terminated2018-06-28
Product Quantity9120 devices

Reason for Recall

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

Firm Action

On May 4, 2017, Philips sent a field safety notice to their consignees. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue: Philips will exchange affected NMT Patient cables at the customer site. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Immediately identify all affected cables, remove them from inventory and hold them for exchange by a Philips Healthcare representative or authorized service provider.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122439INTELLIVUE PATIENT MONITORPhilips Medizin Systeme Boeblingen GmbH · 2012-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑