Z-0264-2016Class II

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

Name: Z-0264-2016 CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Creator: Innokas Medical Oy
Published: 2015-10-22
License: https://open.fda.gov/license/

Innokas Medical Oy / initiated 2015-10-22 / Terminated / root cause: software

FDA source

Innokas Medical Oy began a recall of CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans on 2015-10-22. FDA classified it as Class II and gives the reason as "Monitor may shut down unintentionally without restarting". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0264-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-22
Posted: 2015-11-11
Terminated: 2016-07-01
Recalling firm: Innokas Medical Oy
Product: CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Monitor may shut down unintentionally without restarting.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Innokas Medical, sent a "Urgent Field Safety Notice(s)" dated October 22, 2015 and October 23, 2015 by e-mail to their consignees. The notice informed the distributor of the device, about the deficiency, and correction of the device. The notice included the instructions regarding what to do with the product and information that the devices will be updated. The consignees were instructed to complete and return the Medical Device FSCA/Recall Return Response Acknowledgement and Receipt Form via fax to +358 8 562 3151, mail to: Innokas Medical Oy, Vihikari 10, FI-90440-Kempele, Finland or email to: [email protected]. If you have any questions, contact the QA/RA Director at +358 44 562 3131.
Quantity in commerce: 424 units (38 in US)
Distribution: Worldwide Distribution: US (nationwide) and Europe.
Product codes and lots: 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,SK514150028YA,SK514150029YA,SK514150030YA,SK514150031YA,SK514300002YA, SK514300003YA,SK514300004YA,SK514300005YA,SK514300006YA,SK514300007YA,SK514300008YA, SK514300009YA,SK514300010YA,SK514300011YA,SK514300014YA,SK514300015YA,SK514380001YA, SK514380002YA,SK514380003YA,SK514380004YA,SK514380005YA,SK514380006YA,SK514380007YA, SK514380008YA,SK514380009YA,SK514380010YA,SK514380011YA,SK514380012YA,SK514390001YA, SK514390005YA,SK514390006YA,SK514390007YA,SK514390008YA,SK514390009YA,SK514390010YA, SK514390011YA,SK514390012YA,SK514390013YA,SK514390014YA,SK514390016YA,SK514390017YA, SK514390018YA,SK514390019YA,SK514390020YA,SK514390021YA,SK514390023YA,SK514390024YA, SK514390025YA,SK514390026YA,SK514390027YA,SK514390028YA,SK514390029YA,SK514390030YA, SK514390031YA,SK514390032YA,SK514450001YA,SK514450002YA,SK514450003YA,SK514450004YA, SK514450005YA,SK514450006YA,SK514450008YA,SK514450011YA,SK514450018YA,SK514450021YA, SK514450022YA,SK514460003YA,SK514460004YA,SK514460005YA,SK514460006YA,SK514460007YA, SK514460008YA,SK514460009YA,SK514460010YA,SK514460011YA,SK514460012YA,SK514460013YA, SK514460014YA,SK514460015YA,SK514460016YA,SK514470006YA,SK514470007YA,SK514470008YA, SK514470009YA,SK514470010YA,SK514470011YA,SK514470012YA,SK514470013YA,SK514470014YA, SK514470015YA,SK514470016YA,SK514470018YA,SK514470020YA,SK514470025YA,SK514470026YA, SK514470027YA,SK514470028YA,SK514470029YA,SK514470030YA,SK514470031YA,SK514470032YA, SK514470033YA,SK514470034YA,SK514470035YA,SK514470036YA,SK514470037YA,SK514470038YA, SK514470039YA,SK514470040YA,SK514480003YA,SK514480004YA,SK514480005YA,SK514480006YA, SK514480007YA,SK514480008YA,SK514480009YA,SK514480010YA,SK514480011YA,SK514480012YA, SK514480013YA,SK514480014YA,SK514480015YA,SK514480016YA,SK514480017YA,SK514480018YA,SK514480019YA,SK514480020YA,SK514480021YA,SK514480022YA,SK514480023YA,SK514480024YA, SK514480025YA,SK514480026YA,SK514480027YA,SK514480028YA,SK514480029YA,SK514490018YA, SK514490019YA,SK514500001YA,SK514500002YA,SK514500003YA,SK514500004YA,SK514500005YA, SK514500006YA,SK514500007YA,SK514500008YA,SK514500009YA,SK514500011YA,SK515030069YA, SK515040001YA,SK515040002YA,SK515040003YA,SK515060004YA,SK515070014YA,SK515070015YA, SK515070016YA,SK515090008YA,SK515090009YA,SK515090010YA,SK515090011YA,SK515090012YA, SK515090013YA,SK515090014YA,SK515090015YA,SK515090016YA,SK515100035YA,SK515100036YA, SK515100037YA,SK515100038YA,SK515100039YA,SK515100040YA,SK515100041YA,SK515100042YA, SK515100043YA,SK515100044YA,SK515100045YA,SK515100046YA,SK515100047YA,SK515100048YA, SK515100049YA,SK515100050YA,SK515100054YA,SK515100056YA,SK515100057YA,SK515100058YA, SK515100059YA,SK515100060YA,SK515100061YA,SK515100063YA,SK515100064YA,SK515100066YA, SK515100067YA,SK515100068YA,SK515100069YA,SK515100070YA,SK515100071YA,SK515100072YA, SK515100073YA,SK515100074YA,SK515100075YA,SK515100077YA,SK515100078YA,SK515100079YA, SK515100080YA,SK515100082YA,SK515100083YA,SK515100085YA,SK515100087YA,SK515100088YA, SK515100094YA,SK515100096YA,SK515110001YA,SK515110004YA,SK515110005YA,SK515110006YA, SK515110008YA,SK515110009YA,SK515110010YA,SK515110011YA,SK515110013YA,SK515110019YA, SK515110021YA,SK515110022YA,SK515110023YA,SK515110024YA,SK515110025YA,SK515110026YA, SK515110027YA,SK515110029YA,SK515110031YA,SK515110032YA,SK515110036YA,SK515110037YA, SK515110038YA,SK515110039YA,SK515110040YA,SK515110042YA,SK515110044YA,SK515110046YA, SK515110048YA,SK515110049YA,SK515110054YA,SK515110055YA,SK515110056YA,SK515110057YA, SK515110058YA,SK515110061YA,SK515110067YA,SK515110068YA,SK515110075YA,SK515110076YA, SK515110077YA,SK515110078YA,SK515110079YA,SK515110080YA,SK515110081YA,SK515110082YA, SK515110083YA,SK515110084YA,SK515110085YA,SK515110086YA,SK515110087YA,SK515110088YA, SK515110089YA,SK515110090YA,SK515110091YA,SK515110092YA,SK515110116YA,SK515110117YA, SK515110118YA,SK515110119YA,SK515110120YA,SK515110122YA,SK515110123YA,SK515110124YA, SK515110125YA,SK515110126YA,SK515110127YA,SK515110128YA,SK515110129YA,SK515110130YA, SK515110131YA,SK515110132YA,SK515110133YA,SK515110134YA,SK515110135YA,SK515110136YA, SK515110138YA,SK515110139YA,SK515110140YA,SK515110141YA,SK515110142YA,SK515110143YA, SK515110144YA,SK515110145YA,SK515110146YA,SK515110147YA,SK515110148YA,SK515110149YA, SK515110150YA,SK515110151YA,SK515110152YA,SK515110153YA,SK515110154YA,SK515110155YA, SK515110156YA,SK515110157YA,SK515110158YA,SK515110159YA,SK515110160YA,SK515110161YA, SK515110162YA,SK515110163YA,SK515110164YA,SK515110165YA,SK515110166YA,SK515110168YA, SK515110169YA,SK515110170YA,SK515110171YA,SK515110172YA,SK515110175YA,SK515110176YA, SK515110177YA,SK515110178YA,SK515110181YA,SK515110197YA,SK515110198YA,SK515110199YA, SK515110200YA,SK515110202YA,SK515110203YA,SK515110204YA,SK515110205YA,SK515110206YA, SK515110207YA,SK515110208YA,SK515110214YA,SK515110219YA,SK515110222YA,SK515120010YA, SK515120018YA,SK515120028YA,SK515120030YA,SK515120031YA,SK515120033YA,SK515120034YA, SK515120035YA,SK515130004YA,SK515130005YA,SK515130006YA,SK515170019YA,SK515170022YA, SK514040029YA,SK514100003YA,SK514100005YA,SK514100006YA,SK514100007YA,SK514100010YA, SK514100011YA,SK514100013YA,SK514100014YA,SK514100015YA,SK514100030YA,SK514100031YA, SK514130002YA,SK514130004YA,SK514130005YA,SK514130010YA,SK514130016YA,SK514480032YA, SK514480033YA,SK514480034YA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0264-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0264-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-10

Product code MWI

K133810Class IIVc150 Vital Signs MonitorInnokas Yhtyma / cleared 2014-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)