FDA Device recall Z-0264-2016

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

FDA Device
Class II
terminated
Published 2015-11-18

On 2015-11-18 the FDA classified a Class II recall of CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans by Innokas Medical Oy, citing monitor may shut down unintentionally without restarting.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0264-2016
Classification	Class II
Status	terminated
Initiated	2015-10-22
Published	2015-11-18
Last updated	2026-09-13 11:53 UTC
Company	Innokas Medical Oy
Distribution	US

Product

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

Reason

Monitor may shut down unintentionally without restarting.

Identifiers

code_info	Catalog numbers: 2067980-001, 2067980-002, 2067980-003, 2067980-004, 2067980-005, 2067980-006, 2067980-007, 2067980-008… Catalog numbers: 2067980-001, 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 Serial Numbers: In USA: SK514470004YA,SK514470005YA,SK515050001YA,SK515050002YA,SK515050003YA,SK515050004YA, SK515050005YA,SK515050006YA,SK515050007YA,SK515050008YA,SK515050009YA,SK515050010YA, SK515050011YA,SK515050012YA,SK515050013YA,SK515050014YA,SK515050015YA,SK515050026YA, SK515050027YA,SK515050028YA,SK515050029YA,SK515050030YA,SK515050031YA,SK515050032YA, SK515050033YA,SK515050034YA,SK515050035YA,SK515050036YA,SK515050037YA,SK515050038YA, SK515050039YA,SK515050040YA,SK515050041YA,SK515050042YA,SK515050043YA,SK515050044YA, SK515050045YA,SK515100051YA In Europe: SK514150001YA,SK514150004YA,SK514150005YA,SK514150007YA,SK514150008YA,SK514150009YA, SK514150010YA,SK514150011YA,SK514150019YA,SK514150020YA,SK514150023YA,SK514150026YA, SK514150027YA,SK5141500

code_info

Catalog numbers: 2067980-001, 2067980-002, 2067980-003, 2067980-004, 2067980-005, 2067980-006, 2067980-007, 2067980-008…

Catalog numbers: 2067980-001, 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 Serial Numbers: In USA: SK514470004YA,SK514470005YA,SK515050001YA,SK515050002YA,SK515050003YA,SK515050004YA, SK515050005YA,SK515050006YA,SK515050007YA,SK515050008YA,SK515050009YA,SK515050010YA, SK515050011YA,SK515050012YA,SK515050013YA,SK515050014YA,SK515050015YA,SK515050026YA, SK515050027YA,SK515050028YA,SK515050029YA,SK515050030YA,SK515050031YA,SK515050032YA, SK515050033YA,SK515050034YA,SK515050035YA,SK515050036YA,SK515050037YA,SK515050038YA, SK515050039YA,SK515050040YA,SK515050041YA,SK515050042YA,SK515050043YA,SK515050044YA, SK515050045YA,SK515100051YA In Europe: SK514150001YA,SK514150004YA,SK514150005YA,SK514150007YA,SK514150008YA,SK514150009YA, SK514150010YA,SK514150011YA,SK514150019YA,SK514150020YA,SK514150023YA,SK514150026YA, SK514150027YA,SK5141500

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-0264-2016%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.