RecallRadar

FDA Device recall Z-2199-2012

SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventila…

On 2012-08-22 the FDA classified a Class II recall of SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventila… by Sentec Ag, citing senTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2199-2012
ClassificationClass II
Statusterminated
Initiated2012-07-09
Published2012-08-22
Last updated2026-09-13 11:53 UTC
CompanySentec Ag
DistributionUS

Product

SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

Reason

SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Identifiers

code_info310701 311100 311239 310996 311920 311943 311958 312132

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2199-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.