Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

FDA Device Recall #Z-0264-2016 — Class II — October 22, 2015

Recall Summary

Recall Number Z-0264-2016
Classification Class II — Moderate risk
Date Initiated October 22, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Innokas Medical Oy
Location Kempele, N/A
Product Type Devices
Quantity 424 units (38 in US)

Product Description

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

Reason for Recall

Monitor may shut down unintentionally without restarting.

Distribution Pattern

Worldwide Distribution: US (nationwide) and Europe.

Lot / Code Information

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

Other Recalls from Innokas Medical Oy

Recall # Classification Product Date
Z-2604-2016 Class II CARESCAPE VC150 Vital Signs Monitor; Intended t... Jul 27, 2016
Z-1022-2015 Class II VC150 Vital Signs Monitor (VC150 monitor equipp... Dec 3, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Innokas Medical Oy Recalls by Firm Recall Reasons Device Safety Stats