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Class 2 Device Recall Eye Cubed Ultrasound System |
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Date Initiated by Firm |
September 25, 2007 |
Date Posted |
December 28, 2007 |
Recall Status1 |
Terminated 3 on September 08, 2008 |
Recall Number |
Z-0148-2008 |
Recall Event ID |
45398 |
510(K)Number |
K041947
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Product Classification |
Ultrasound System - Product Code IYO
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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 CA 95827-1713
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For Additional Information Contact |
916-363-0774
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = IYO and Original Applicant = INNOVATIVE IMAGING, INC.
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