CARESCAPE VC150 Vital Signs Monitor — Class II medical device recall Z-2604-2016
Terminated recall by INNOKAS MEDICAL OY, reported 2016-08-31, distributed in AR, AZ, FL, IN, LA, MA, MI, NC…. A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurem
| Recall number | Z-2604-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | INNOKAS MEDICAL OY, KEMPELE, Finland |
| Recall initiated | 2016-07-27 |
| Classified | 2016-08-19 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-04-19 |
| Distributed | AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI |
| Quantity | 1,715 units |
| Reason classes | software |
Product
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Reason for recall
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
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-2604-2016. 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.