| Class 2 Device Recall Expression MR200 MRI Patient Monitoring System | |
Date Initiated by Firm | September 05, 2014 |
Date Posted | October 15, 2014 |
Recall Status1 |
Terminated 3 on October 12, 2017 |
Recall Number | Z-0069-2015 |
Recall Event ID |
69179 |
510(K)Number | K131382 |
Product Classification |
Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
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Product | Philips Expression MR200 MRI Patient Monitoring System |
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. |
Recalling Firm/ Manufacturer |
Invivo Corporation 12151 Research Pkwy Suite 200 Orlando FL 32826-3222
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For Additional Information Contact | Debra Levasseur 407-275-3220 Ext. 171 |
Manufacturer Reason for Recall | Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. |
FDA Determined Cause 2 | Process control |
Action | Philips Medical Systems sent an Urgent - Medical Device Correction letter dated July 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Our records indicate that you have an affected device. The following page provides additional instructions and actions that will be taken to address this problem.
If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MWI
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