Recall Z-2951-2020 ยท LLZ System, Image Processing, Radiological
SICAT GMBH & CO. KG
SICAT IMPLANT V2.0
| Date | Jul 15, 2020 |
| Status | Terminated |
| Reason | A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD. |
| Root cause | Software design |
| Action | On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found. |
| Quantity | 853 units |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192348 | SICAT Implant V2.0 Sicat GmbH & Co. KG, Dec 4, 2019 |