Recall Z-0148-2008 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Ellex Inc.
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
| Date | Dec 28, 2007 (initiated Sep 25, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041947 | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND Innovative Imaging, Inc., Aug 16, 2004 |