Z-1022-2015Class II

VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE...

Name: Z-1022-2015 VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE...
Creator: Innokas Medical Oy
Published: 2014-12-03
License: https://open.fda.gov/license/

Innokas Medical Oy / initiated 2014-12-03 / Terminated / root cause: software

FDA source

INNOKAS MEDICAL OY began a recall of VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers... on 2014-12-03. FDA classified it as Class II and gives the reason as "If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms". 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-1022-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-03
Posted: 2015-01-28
Terminated: 2015-04-24
Recalling firm: Innokas Medical Oy
Product: VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
Root cause tag: software
FDA root cause: Software design
Action: A notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair.
Quantity in commerce: 20 units
Distribution: Distributed in the US and Europe.
Product codes and lots: SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1022-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1022-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-28

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)