FDA recall Z-1322-2019

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2019-04-19

Report date

2019-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2019