CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
Carescape VC150 Vital Signs Monitor vital signs in humans recalled
Innokas Medical Oy is recalling Carescape VC150 Vital Signs Monitor vital signs in humans, distributed nationwide in the US. The recall was initiated on 22 Oct 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0264-2016
- FDA event ID
- 72475
- Recalling firm
- Innokas Medical Oy, Kempele, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2015
- FDA classified
- 10 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 22 Oct 2015 | Recall initiated by company | |
| 10 Nov 2015 | Classified by FDA | +19 days |
| 18 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Monitor may shut down unintentionally without restarting.
Product as listed by the FDA
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Where it was distributed
Worldwide Distribution: US (nationwide) and Europe.
Questions about this recall
Why was it recalled?
Monitor may shut down unintentionally without restarting.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution: US (nationwide) and Europe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Innokas Medical Oy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Carescape VC150 Vital Signs Monitor recalled by Innokas Medical Oy | Innokas Medical OY | Device Malfunction | 15 states |
| Device | CLASS II | VC150 Vital Signs Monitor (VC150 monitor equipped recalled | Innokas Medical OY | Device Malfunction | N/A |
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