Recall Z-2175-2017— Philips Electronics North America Corporation

Name: FDA recall Z-2175-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-04

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-05-04, terminated 2018-06-28. It names one FDA 510(k) clearance: K122439. Product: NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383). Reason: Manufacturing defect may cause localized heating, which may result in localized skin burn..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-05-04
Terminated: 2018-06-28
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122439 — INTELLIVUE PATIENT MONITORPhilips Medizin Systeme Boeblingen GmbH·cleared 2012-08-29

K-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

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.