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Terminated

Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits). Label located on the back of the WPU. Product is labeled in part: "***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando, FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Display Controller Unit (DCU) is labeled in part: "***Invivo***PRECESS***". Wireless Processing Unit (WPU) is labeled in part: "***Invivo***". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS. The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures.

FDA Recall Z-0113-2012 · Posted 2011-10-27

Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2011-09-23
Date Terminated2013-08-07
Product Quantity875

Reason for Recall

Philips Invivo has determined that it is possible for the system's alarm limits and other device settings to spontaneously change without user intervention. This problem is associated with intermittent and frequent loss of communication between the wireless Processing Unit and the Display Controller Unit.

Firm Action

A Field Safety Notice entitled Urgent - Medical Device Correction letter, dated September 2011, with attached Field Safety Notice for customers were sent to distributors. The letter described the reason for the recall and the intention of the Field Safety Notice. Also, the hazards involved and instructions on how to identify units that are affected by the recall were provided . The actions to be taken by the user and the actions planned by the Philips Invivo were explained. Users were to follow the instructions provided on how to safely use the device until the unit can be serviced by Philips Invivo. For further information or support concerning this issue, customers are to contact Philips Invivo Customer Support at (877)-468-4861 or their local Philips Invivo representative.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- Australia, Austria, Brazil, Canada, China, France, Germany, Malaysia, Norway, Portugal, Spain, Sweden, The Netherlands, United Arab Emirates, United Kingdom, and US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0534623160 MRI PATIENT MONITORING SYSTEMInvivo Corporation · 2006-01-18

Official Source

View FDA Recall →

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

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