Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended fo

FDA device recall Z-0468-2013 · posted 2012-12-04 · Terminated

Recall details

Recalling firm

Invivo Corporation

Reason for recall

Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall.

Action taken

Philips Healthcare sent an "URGENT-MEDICAL DEVICE RECALL" letter dated October 15, 2012 to all affected customers. The letter identified the product, problem, and actons to be taken by the customers. Customers were instructed to inspect all casters of the unit to ensure that they are all secured. If a caster is loose, customers were told to lock the caster in place, limit movement of the cart and contact their local Phillips Invivo Representative. Nevertheless, a Philips Invivo representative will contact the customer regarding their affected device. All affected devices will have new casters installed in order to correct the problem. Contact your local Philips Invivo Representative at 1-800-722-9377 for further information and support.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MWI

Quantity affected

543 units

Distribution

Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL;

Date initiated

2012-10-15

Date posted

2012-12-04

Date terminated

2015-02-13

Location

Orlando, FL

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