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U.S. Department of Health and Human Services

Class 2 Device Recall SureSigns VS3 Vital Signs Monitor

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  Class 2 Device Recall SureSigns VS3 Vital Signs Monitor see related information
Date Initiated by Firm April 30, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on March 29, 2017
Recall Number Z-1911-2008
Recall Event ID 47886
510(K)Number K052707  
Product Classification Patient Physiological Monitor with arrhythmia detection and alarms - Product Code MHX
Product Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, recording and alarming of multiple physiological parameters.
Code Information SureSigns VS3; Model numbers 863071, 863072, 863073, 863074
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Peter Ohanian
978-687-1501
Manufacturer Reason
for Recall		 Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood pressure (NBP) mode. These alarms are only enabled when interval NBP mode is selected. If when monitoring SpO2, the clinician does not notice when the sensor is no longer attached, the patient is not being monitored through Spo2.This could result in delay or lack of needed therapy. The labeling provided with the monitor did not fully describe this feature.
FDA Determined
Cause 2		 Labeling design
Action All affected customers will receive the FSN (Field Safety Notice )informing them about the labeling correction. Included with the FSN will be an addendum to the instructions for use. customers are asked to read the addendum and insert a copy into each of their copies of the VS3 instructions for use. Customers will also receive a Medical Device Correction Confirmation Card that they will be asked to fill out and fax back to their local Philips representative. Contact your local Philips support organization at 1-800-722-9377 in the United States or 1-800-323-2280 in Canada.
Quantity in Commerce 7,529 units
Distribution Worldwide Distribution to United States, Canada and Foreign countries
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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