Recall Z-1022-2015— INNOKAS MEDICAL OY
Class II · Terminated
Class II FDA medical device recall by INNOKAS MEDICAL OY, initiated 2014-12-03, terminated 2015-04-24. It names one FDA 510(k) clearance: K133810. 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.. 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..
- Recalling firm
- INNOKAS MEDICAL OY
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-03
- Terminated
- 2015-04-24
- Firm location
- KEMPELE, N/A, Finland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.