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U.S. Department of Health and Human Services

Class 2 Device Recall CARESCAPE VC150 Vital Signs Monitor

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 Class 2 Device Recall CARESCAPE VC150 Vital Signs Monitorsee related information
Date Initiated by FirmDecember 03, 2014
Date PostedJanuary 28, 2015
Recall Status1 Terminated 3 on April 24, 2015
Recall NumberZ-1022-2015
Recall Event ID 70068
510(K)NumberK133810 
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
ProductVC150 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.
Code Information SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA
Recalling Firm/
Manufacturer		 INNOKAS MEDICAL OY
TARJUSOJANTIE 12
KEMPELE Finland
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionA notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair.
Quantity in Commerce20 units
DistributionDistributed in the US and Europe.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MWI
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