Recall Z-1592-2011 ยท LLZ System, Image Processing, Radiological
Straumann Manufacturing Inc.
Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10
| Date | Mar 7, 2011 (initiated Sep 30, 2010) |
| Status | Terminated |
| Reason | Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve. |
| Root cause | Software design |
| Action | Straumann notified accounts of this correction by letter dated September 30, 2010 and delivered via Federal Express Delivery Service. The upgrade is available on-line by logging into the coDiagnostiX system and enabling the automatic upgrade to occur. |
| Quantity | 20 systems |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071636 | CODIAGNOSTIX (R) 5.72 Ivs Solutions AG, Aug 9, 2007 |