Data Foundry

Medical device recalls 2015

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans — Class II medical device recall Z-0264-2016

Terminated recall by Innokas Medical Oy, reported 2015-11-18, distributed nationwide. Monitor may shut down unintentionally without restarting.

Recall numberZ-0264-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmInnokas Medical Oy, Kempele, N/A, Finland
Recall initiated2015-10-22
Classified2015-11-10
Reported by FDA2015-11-18
Terminated2016-07-01
DistributedNationwide (US)
Quantity424 units
Serial numbersSK514470004YA, SK514470005YA, SK515050001YA, SK515050002YA, SK515050003YA, SK515050004YA, SK515050005YA, SK515050006YA, SK515050007YA, SK515050008YA, SK515050009YA, SK515050010YA, SK515050011YA, SK515050012YA, SK515050013YA, SK515050014YA, SK515050015YA, SK515050026YA, SK515050027YA, SK515050028YA, SK515050029YA, SK515050030YA, SK515050031YA, SK515050032YA, SK515050033YA and 13 more
Model numbers2067980-001, 2067980-002, 2067980-003, 2067980-004, 2067980-005, 2067980-006, 2067980-007, 2067980-008, 2067980-009, 2067980-010, 2067980-011, 2067980-012, 2067980-013, 2067980-014, 2067980-015, 2067980-016

Product

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

Reason for recall

Monitor may shut down unintentionally without restarting.

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-0264-2016. 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.