CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
FDA device recall Z-2604-2016 · posted 2016-08-19 · Terminated
Recall details
- Recalling firm
- INNOKAS MEDICAL OY
- Reason for recall
- 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 taken
- Innokas Medical has notified the one US distributor on 7/27/16 via letter of the deficiency and correction of the device.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 1715 units
- Distribution
- AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI
- Date initiated
- 2016-07-27
- Date posted
- 2016-08-19
- Date terminated
- 2017-04-19
- Location
- KEMPELE, Finland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VC150 VITAL SIGNS MONITOR (K133810) | Innokas Yhtyma | 2014-10-30 |