FDA Recall
Terminated
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Recall: Z-2604-2016
·
Initiated July 27, 2016
Recall
- Recall Number
- Z-2604-2016
- Event Number
- 74884
- Firm
- INNOKAS MEDICAL OY TARJUSOJANTIE 12 KEMPELE Finland
- FEI Number
- 3007615597
- Product Code
- MWI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- July 27, 2016
- Posted
- August 19, 2016
- Terminated
- April 19, 2017
Description
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Reason
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
Action
Innokas Medical has notified the one US distributor on 7/27/16 via letter of the deficiency and correction of the device.
Distribution
AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI
Quantity
1715 units