Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.

FDA Recall Z-1022-2015 · Posted 2015-01-28

Recalling FirmINNOKAS MEDICAL OY
Recall StatusTerminated
Product CodeMWI
Date Initiated2014-12-03
Date Terminated2015-04-24
Product Quantity20 units

Reason for Recall

If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.

Firm Action

A notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair.

Root Cause

Software design

Distribution Pattern

Distributed in the US and Europe.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑