CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report

Philips Expression MR200 MRI Patient Monitoring System recalled

Invivo is recalling Philips Expression MR200 MRI Patient Monitoring System, distributed in 11 states. The recall was initiated on 22 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.

Quantity recalled20

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0958-2015
FDA event ID: 69587
Recalling firm: Invivo, Orlando, FL
Classification: Class II
Status: Terminated
Recall initiated: 22 Oct 2014
FDA classified: 13 Jan 2015
Reported: 21 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

22 Oct 2014	Recall initiated by company
13 Jan 2015	Classified by FDA	+83 days
21 Jan 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.

Product as listed by the FDA

Philips Expression MR200 MRI Patient Monitoring System.

Where it was distributed

CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.

California Florida Indiana Kentucky Minnesota North Carolina New Jersey New York Oklahoma South Dakota Texas

Questions about this recall

Why was it recalled?

The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.

Which lots are affected?

Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.

Where was it sold?

CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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