VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx O
FDA device recall Z-1022-2015 · posted 2015-01-28 · Terminated
Recall details
- Recalling firm
- INNOKAS MEDICAL OY
- 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.
- Action taken
- A notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 20 units
- Distribution
- Distributed in the US and Europe.
- Date initiated
- 2014-12-03
- Date posted
- 2015-01-28
- Date terminated
- 2015-04-24
- Location
- KEMPELE, Finland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VC150 VITAL SIGNS MONITOR (K133810) | Innokas Yhtyma | 2014-10-30 |