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U.S. Department of Health and Human Services

Class 3 Device Recall SureSigns

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  Class 3 Device Recall SureSigns see related information
Date Initiated by Firm September 20, 2017
Date Posted December 20, 2017
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-0268-2018
Recall Event ID 78733
510(K)Number K112652  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Code Information SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279 
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Yini He
978-659-3000
Manufacturer Reason
for Recall		 Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
FDA Determined
Cause 2		 Error in labeling
Action Philips sent each known affected customer a Field Safety Notice, dated September, 2017. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will provide a corrected label free of charge
Quantity in Commerce 1079
Distribution Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlands, Oman, Pakistan, Palestine, Poland, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Turkey, United Kingdom, UAE, Vietnam, and Zimbabwe.
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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