Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits).

FDA device recall Z-0113-2012 · posted 2011-10-27 · Terminated

Recall details

Recalling firm

Invivo Corporation

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.

Action taken

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

Status

Terminated

Product code

MWI

Quantity affected

875

Distribution

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

Date initiated

2011-09-23

Date posted

2011-10-27

Date terminated

2013-08-07

Location

Orlando, FL

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