Z-0468-2013Class II

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

Name: Z-0468-2013 Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is...
Creator: Invivo Corporation
Published: 2012-10-15
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2012-10-15 / Terminated / root cause: manufacturing process

FDA source

Invivo Corporation began a recall of Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to... on 2012-10-15. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0468-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-15
Posted: 2012-12-04
Terminated: 2015-02-13
Recalling firm: Invivo Corporation
Product: Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; CO; MN; CA; IN; MD; MI; DC; GA; DE; CO; CT; WA; NJ; MD; TX; TN; MN; WA; CA; FL; OH; PA; NY; IN; OK; ID; IA; NY; WI; VA; CA; HI; MS; TX; HI; CT; TN; OR; WA; PA; NH; CA; MA; LA; IN; PA; AZ; GA; UT; ND; GA; TX; TX; IN; CA; MI; CT; CA; NC; MS; VA; IN; MI; NE; NV; MI; WA; IL; KY; LA; OR; OK; LA; TN; KY; TX; CA; PA; NM; NC; CO; DC; AL; MI; TX; SD; PA; OR; ID; NM; SD; CO; MN; NJ; MI; ND; MN; MT; LA; CT; WA; TX; IA; NJ; WI; SD; and UT, and the countries of Canada, Italy, Thailand, Russian Federation, Saudi Arabia, Slovenia, Singapore, Republic of Korea, Uzbekistan, Iceland, Israel, Austria, United Kingdom, Afganhistan, Japan, South Africa, Germany, Qatar, Netherlands, Switzerland, Denmark, and Sweden.
Product codes and lots: Model number 865214: (Service Numbers 453564180091, 453564181201). 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0468-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0468-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

Product code MWI

K090785Class IIMRI Compatible Patient Monitoring System, Model 865214Invivo Corp. / cleared 2009-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)