Z-0148-2008

Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan...

Name: Z-0148-2008 Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan...
Creator: Ellex Inc.
Published: 2007-09-25
License: https://open.fda.gov/license/

Ellex Inc. / initiated 2007-09-25 / Terminated / root cause: software

FDA source

Ellex Inc. began a recall of 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 on 2007-09-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0148-2008
Status: Terminated
Initiated: 2007-09-25
Posted: 2007-12-28
Terminated: 2008-09-08
Recalling firm: Ellex Inc.
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
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Product code IYO

K041947Class III3 System-Abd Diagnostic UltrasoundInnovative Imaging, Inc. / cleared 2004-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)