Z-0001-2015Class II

Philips Expression MR200 MRI Patient Monitoring System Model 866120

Name: Z-0001-2015 Philips Expression MR200 MRI Patient Monitoring System Model 866120
Creator: Invivo Corporation
Published: 2014-09-08
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2014-09-08 / Terminated / root cause: manufacturing process

FDA source

Invivo Corporation began a recall of Philips Expression MR200 MRI Patient Monitoring System Model 866120 on 2014-09-08. FDA classified it as Class II and gives the reason as "During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to...". 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-0001-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-08
Posted: 2014-10-01
Terminated: 2017-01-09
Recalling firm: Invivo Corporation
Product: Philips Expression MR200 MRI Patient Monitoring System Model 866120
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, Philips Healthcare, sent an "URGENT- Medical Device Recall" letter dated June 17, 2014, to its customers informing them of the product, problem and actions taken. The firm informed the customers that there are no additional actions required on their part. The Philips/Invivo Account Manager will contact them in order to arrange for replacement of the device. If you need any further information or support concerning this issue, contact your local Philips/Invivo representative: 877-468-4861 option 1, then option 2.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
Product codes and lots: Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0001-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-01

Product code MWI

K131382Class IIExpression Mr200 MRI Patient Monitoring System, Expression Ip5 Information PortalInvivo Corporation / cleared 2013-07-15

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)