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Terminated

Invivo Expression MRI Patient Monitoring System.

FDA Recall Z-2266-2015 · Posted 2015-07-27

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2015-06-17
Date Terminated2019-10-02
Product Quantity697 devices.

Reason for Recall

The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal.

Firm Action

An URGENT Medical Device Correction was sent to all consignees by letter June 2015 regarding the Invivo Expression MRI Patient Monitoring System FlexTEMP Application Site explaining the reason for the affected labeling.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OR, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Alaska, Hawaii and the District of Columbia, and the countries of Argentina, Australia, Austria, Canada, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, Iceland, Israel, Italy, Japan, Netherlands, Norway, Oman, Poland, Portugal, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, United Arab Emirates, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K124061MRI PATIENT MONITORING SYSTEM (MODEL 865214)Invivo Corporation · 2013-02-22

Official Source

View FDA Recall →

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

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