Recall Z-0113-2012 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
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 me
| Date | Oct 27, 2011 (initiated Sep 23, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 Phil |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053462 | 3160 MRI PATIENT MONITORING SYSTEM Invivo Corporation, Jan 18, 2006 |