CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
FDA device recall Z-0264-2016 · posted 2015-11-11 · Terminated
Recall details
- Recalling firm
- Innokas Medical Oy
- Reason for recall
- Monitor may shut down unintentionally without restarting.
- Action taken
- The firm, Innokas Medical, sent a "Urgent Field Safety Notice(s)" dated October 22, 2015 and October 23, 2015 by e-mail to their consignees. The notice informed the distributor of the device, about the deficiency, and correction of the device. The notice included the instructions regarding what to do with the product and information that the devices will be updated. The consignees were instructed to complete and return the Medical Device FSCA/Recall Return Response Acknowledgement and Receipt Form via fax to +358 8 562 3151, mail to: Innokas Medical Oy, Vihikari 10, FI-90440-Kempele, Finland or email to: feedback@innokasmedical.fi. If you have any questions, contact the QA/RA Director at +358 44 562 3131.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 424 units (38 in US)
- Distribution
- Worldwide Distribution: US (nationwide) and Europe.
- Date initiated
- 2015-10-22
- Date posted
- 2015-11-11
- Date terminated
- 2016-07-01
- Location
- Kempele, Finland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VC150 VITAL SIGNS MONITOR (K133810) | Innokas Yhtyma | 2014-10-30 |