Home / Recalls / INNOKAS MEDICAL OY / Z-1022-2015

Z-1022-2015 Class II Terminated

Recalled by INNOKAS MEDICAL OY — KEMPELE, N/A

Recall Details

Product Type: Devices
Report Date: February 4, 2015
Initiation Date: December 3, 2014
Termination Date: April 24, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20 units

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.

Distribution Pattern

Distributed in the US and Europe.

Code Information

SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA