Recall Z-3184-2011 ยท LLZ System, Image Processing, Radiological
Straumann Manufacturing Inc.
Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. Imaging processing System
| Date | Sep 13, 2011 (initiated Aug 4, 2011) |
| Status | Terminated |
| Reason | Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed. |
| Root cause | Software design |
| Action | Staumann USA notified accounts by an Urgent Field Safety Notice letter dated August 4, 2011 and delivered via Federal Express Delivery Service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review the letter, take appropriate actions, including completing and faxing the enclosed. Customer Confirmation Form. Straumann released a corrected software upgrade (coDiagnostiX 8.0.2.3672), which is available for download when users go online and activate current software. If the user does not have internet access a replacement CD can be |
| Quantity | 272 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071636 | CODIAGNOSTIX (R) 5.72 Ivs Solutions AG, Aug 9, 2007 |