Reported Feb 4, 2015 · Terminated
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx…
Innokas Medical Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INNOKAS MEDICAL OY · TARJUSOJANTIE 12 · KEMPELE, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
SK514470022YASK514470023YASK514470024YASK514470020YASK514470021YASK514100003YASK514470019YASK514470001YASK514470017YASK514470018YASK514450021YASK514450022YASK514450019YASK514470004YASK514470005YASK514390001YASK514150002YASK514150004YASK514150005YASK514300002YA
- Amount recalled
- 20 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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