Z-0069-2015 Class II Terminated
FDA device recall Z-0069-2015 was initiated by Invivo Corporation on September 5, 2014 and is designated Class II. Reason for recall: Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. The recall status is terminated (terminated October 12, 2017). Affected quantity: 24 units..
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.