FDAClass IIOctober 22, 2014

Philips Expression MR200 MRI Patient Monitoring System recall

Philips Expression MR200 MRI Patient Monitoring System

Why was Philips Expression MR200 MRI Patient Monitoring System recalled?

Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.

Product
Philips Expression MR200 MRI Patient Monitoring System
Recalling firm
Invivo Corporation
Quantity
24 units.
Distribution
Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.
Recall date
October 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls