Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.

FDA Recall Z-0543-2010 · Posted 2009-12-17

Recalling FirmImaging Sciences International, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-10-30
Date Terminated2010-09-30
Product Quantity98 units

Reason for Recall

overhead carriage drops quickly

Firm Action

Imaging Sciences International issued an "Urgent Medical Device Recall" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit. For further information, contact Imaging Sciences International at 1-800-205-3570, option 5.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051980DVT SCANNERImaging Sciences Intl., Inc. · 2005-08-19

Official Source

View FDA Recall →

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

↑