FDA Medical Device Recalls (openFDA)
INNOKAS MEDICAL OY: 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.
- Recall number
- Z-1022-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-12-03
- Posted
- 2015-01-28
- Terminated
- 2015-04-24
- Reason
- 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
- 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
- 20 units
- Distribution
- Distributed in the US and Europe.
- Lot, serial or model codes
- SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA
- 510(k) numbers
- ["K133810"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 3007615597
- Firm city
- KEMPELE
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28