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U.S. Department of Health and Human Services

Class 2 Device Recall Eye Cubed Ultrasound System

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 Class 2 Recall
Eye Cubed Ultrasound System
see related information
Date Posted December 28, 2007
Recall Status1 Terminated on September 08, 2008
Recall Number Z-0148-2008
Recall Event ID 45398
Premarket Notification
510(K) Number
K041947 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product 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
Code Information 59 systems are affected with serial numbers: V305-00510 V307-18205 V307-18405 V307-20309 V307-20409 V307-20609 V307-20809 V307-20909 V307-21409 V307-19605 V307-15703 V307-16404 V307-16504 V307-19805 V307-17304 V307-18105 V307-19105 v307-14303 v306-09910 v307-13902 v306-05705 v307-17104 v307-17004 v307-14203 v307-14903 v307-17502 v307-15203 v307-18305 v307-15503 v306-04605 v307-18905 v307-16003 v307-18605 v307-18004 v307-16904 V307-21009 v307-14803 V307-20005 v307-17904 v307-19505 v307-12302 v307-21109 V307-21509 v307-11101 v307-19305 v307-21209 v307-17404 v307-18705 v307-18505 v307-16304 V306-07108 v306-09209 v306-04405 V306-06408 v307-19205 V307-20209 v307-19005 v306-12104 v307-19905
Recalling Firm/
Manufacturer
Ellex Inc.
9940 Business Park Dr Ste 155
Sacramento, California 95827-1713
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 59
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = INNOVATIVE IMAGING, INC.
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