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Recall Observatory FDA recall evidence

Device product

Philips Expression MR200 MRI Patient Monitoring System

Z-0069-2015

September 05, 2014

Class II

Product summary

Firm
Invivo Corporation
Event
Event 69179
Status
Terminated
Classification
Class II
Quantity
24 units.
Official record key
device-enforcement:Z-0069-2015

Official wording

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

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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