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Terminated

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

FDA Recall Z-0264-2016 · Posted 2015-11-11

Recalling FirmInnokas Medical Oy
Recall StatusTerminated
Product CodeMWI
Date Initiated2015-10-22
Date Terminated2016-07-01
Product Quantity424 units (38 in US)

Reason for Recall

Monitor may shut down unintentionally without restarting.

Firm Action

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: [email protected]. If you have any questions, contact the QA/RA Director at +358 44 562 3131.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: US (nationwide) and Europe.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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