# FDA recall Z-1318-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-04-19.

## Product

SureSigns VS3 NBP Temp, Product Number 863070.  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

- **Recall number:** Z-1318-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-04-19
- **Report date:** 2019-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2019

## Citation

> AI Analytics. FDA recall Z-1318-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1318-2019. Source: US FDA. Licensed CC0.

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