Recall Z-0106-2012 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
"***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expres
| Date | Oct 25, 2011 (initiated Aug 30, 2010) |
| Status | Terminated |
| Reason | Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall. |
| Root cause | Device Design |
| Action | Philips Invivo Corporation issued a Field Safety Notice "URGENT - MEDICAL DEVICE RECALL" letter to all affected customers notifying them that the Expression MRI Patient Monitoring System could pose a risk for patients and users. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the user in order to prevent risks for patients or users and the actions planned by Philips Invivo to correct the problem. This notice contains important information for the continued safe and proper use of the equipment and customers |
| Quantity | 285 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI., SC, SD, TN, TX, VA, WA, and WI and the countries of: Australia, Austria, Canada, Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 Invivo Corp., Dec 15, 2009 |