"***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring S

FDA device recall Z-0106-2012 · posted 2011-10-25 · Terminated

Recall details

Recalling firm

Invivo Corporation

Reason for recall

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.

Action taken

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 were advised to retain a copy with the equipment Instruction for Use. Customers were instructed to contact Philips Invivo Customer Support at (877) 468-4861 (option 1, then option 3) for questions or support concerning this issue.

Root cause

Device Design

Status

Terminated

Product code

MWI

Quantity affected

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, P

Date initiated

2010-08-30

Date posted

2011-10-25

Date terminated

2012-11-15

Location

Orlando, FL

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