VC150 Vital Signs Monitor — Class II medical device recall Z-1022-2015
Terminated recall by INNOKAS MEDICAL OY, reported 2015-02-04. If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode,
| Recall number | Z-1022-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | INNOKAS MEDICAL OY, KEMPELE, N/A, Finland |
| Recall initiated | 2014-12-03 |
| Classified | 2015-01-28 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2015-04-24 |
| Quantity | 20 units |
| Model numbers | 2067980-002, 2067980-006, 2067980-010, 2067980-014 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1022-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.