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Terminated

Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex Innovative Imaging, Sacramento, CA 95827

FDA Recall Z-0148-2008 · Posted 2007-12-28

Recalling FirmEllex Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2007-09-25
Date Terminated2008-09-08
Product Quantity59

Reason for Recall

Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.

Firm Action

A Global Customer Service Bulletin (GCSB)-Urgent Notification of Software Correction was issued on 25 September 2007, which provided short term workaround directions pending a free software undate promised in the near future.

Root Cause

Software design

Distribution Pattern

Worldwide; including Canada and Mexico. U.S.A. distribution included states of AL, AZ, CA, CT, FL, GA, IL, MA, ME, MI, MN, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TN, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041947I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUNDInnovative Imaging, Inc. · 2004-08-16

Official Source

View FDA Recall →

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

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