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Recall Observatory FDA recall evidence

Device 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.

Z-1022-2015

December 03, 2014

Class II

Product summary

Firm
INNOKAS MEDICAL OY
Event
Event 70068
Status
Terminated
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-1022-2015

Official wording

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.

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

Distribution pattern: Distributed in the US and Europe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.