High FDA (Devices)·Z-2604-2016·Announced 2016-08-31

Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Software Error

Innokas Medical Oy is recalling 1,715 CARESCAPE VC150 Vital Signs Monitors because a software error may provide incorrect time data to measurements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the device is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Innokas Medical Oy is recalling 1,715 units of the CARESCAPE VC150 Vital Signs Monitor. The device is intended to monitor a single patient's vital signs at the site of care. The recall affects specific software versions 1.6.12, 1.6.12F, and 1.6.16.

The recall was initiated because a software error in these versions may give wrong time data to measurements. The affected units were distributed in 15 states: AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, and WI.

Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice and contact Innokas Medical Oy for instructions on how to proceed.

The recalled product

Product: CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Manufacturer: INNOKAS MEDICAL OY
Category: Medical Device — Vital Signs Monitor
Hazard: software-error
incorrect-data
Affected units: 1,715

Distribution

Distributed in 15 states:

Same manufacturer · INNOKAS MEDICAL OY

See all →

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Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Shutdown Defect
FDA (Devices) · 2015-11-18
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Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure
FDA (Devices) · 2015-02-04

Same hazard · software error