SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reported: May 22, 2019 Initiated: April 19, 2019 #Z-1322-2019
Product Description
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
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.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 12719
- 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.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).. Recalled by Philips North America, LLC. Units affected: 12719.
Why was this product recalled? ▼
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Moderate. Recall number: Z-1322-2019.
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