Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex In
FDA device recall Z-0148-2008 · posted 2007-12-28 · Terminated
Recall details
- Recalling firm
- Ellex Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 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.
- Date initiated
- 2007-09-25
- Date posted
- 2007-12-28
- Date terminated
- 2008-09-08
- Location
- Sacramento, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (K041947) | Innovative Imaging, Inc. | 2004-08-16 |