FDA Device recall Z-1318-2019
SureSigns VS3 NBP Temp, Product Number 863070
- FDA Device
- Class II
- ongoing
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of SureSigns VS3 NBP Temp, Product Number 863070 by Philips North America, citing system software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1318-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-04-19 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Identifiers
| code_info | Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1318-2019%22
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