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Class 2 Device Recall IntelliVue Patient Monitoring |
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Date Initiated by Firm |
April 04, 2014 |
Date Posted |
May 16, 2014 |
Recall Status1 |
Terminated 3 on November 07, 2017 |
Recall Number |
Z-1628-2014 |
Recall Event ID |
67923 |
510(K)Number |
K110622
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Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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Product |
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters. |
Code Information |
Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0. |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact |
800-722-9377
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Manufacturer Reason for Recall |
The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
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FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
Philips sent an Urgent: Medical Device Correction letter dated April 4, 2014 to all affected customers. The letter identified the affected product, problem, action to be taken and instructions for Use Addendum. Customers were instructed to review this information with all staff members who are involved in the operation and battery management of the IntelliVue patient Monitors and need to be aware of the contents of this communication. The addendum should be stored with the Monitor Instructions for Use. Please contact your local Philips representative or call us at 1-800-722-9377 with questions or concerns about this correction. |
Quantity in Commerce |
188,520 devices |
Distribution |
Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Turkey. |
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 = MHX and Original Applicant = PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
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