Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SureSigns VS3 NBP, SpO2

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SureSigns VS3 NBP, SpO2 see related information
Date Initiated by Firm April 19, 2019
Create Date May 13, 2019
Recall Status1 Open3, Classified
Recall Number Z-1319-2019
Recall Event ID 82684
510(K)Number K163649  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Code Information Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer Reason
for Recall		 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
FDA Determined
Cause 2		 Software design
Action On April 19, 2019 Philips Healthcare issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. Actions to be taken by customer: Upon receipt of this notification, promptly perform the software upgrade to each of your SureSigns VS3/VS4 monitors, as called out in the attached Pulse Rate Software-Installation Instructions. It details how to obtain and install the system software update. It also provides instructions on how to export the file that is created during software installation and instructions where to email the file back to Philips. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.
Quantity in Commerce 12543
Distribution Worldwide distribution. US Nationwide including Puerto Rico, Andorra, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Dominican Republic, Egypt, France, French Guiana, French Polynesia, Germany, Gibraltar, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea Republic, Kosovo, Kuwait, Latvia, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Martinique, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Philippines, Portugal, Qatar, Reunion, Romania, Rwanda, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Kingdom, United Arab Emirates,Venezuela, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = Philips Medical Systems
-
-