Z-0069-2015 Class II Terminated

Recalled by Invivo Corporation — Orlando, FL

Recall Details

Product Type
Devices
Report Date
October 22, 2014
Initiation Date
September 5, 2014
Termination Date
October 12, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 units.

Product Description

Philips Expression MR200 MRI Patient Monitoring System

Reason for Recall

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

Distribution Pattern

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.

Code Information

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.