||September 13, 2011
||Terminated on May 23, 2012
|Recall Event ID
System, Image Processing, Radiological - Product Code LLZ
||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
||Software version 8.0 as listed below:
listed are the affected articles.
019,0385 @ Upgrade cDX 8 PPP (7+)
019,0386 @ Upgrade cDX 8 Station (7+)
019.0387 @ Upgrade cDx 8 coDoctor (7+)
019.0388 @ Upgrade cDX coDoctor (7+) > PPP 8
0'19.0389 @ Upgrade cDX codoctor (7+) > PPG 8
019.0390 @ Upgrade cDX coDoctor (7+) >Station 8
019.0391 @ Upgrade cDX PPP (7 +):> PPG 8
019.0392 @ Upgrade cDX PPP (7+):> Station 8
019.0393 @ Upgrade coDX PPP > Station 8
019.0378 Upgrade coDiagnostix 8 PPP (7-)
0'19.0379 Upgrade coDiagnostiX 8 Station (7-)
019.0380 Upgrade coDiagnostiX 8 coDoctor (7-)
019.0381 Upgrade coDoctor (7-) -> PPP 8
019.0382 Upgrade coDoctor (7-) -> PPG8
019.0383 Upgrade PPP (7-) -> PPG 8
019.0384 coDiagnostiX CD
019.0370 coDiagnostiX 8 PPP
019.0371 coDiagnostiX 8 PPG
0'19.0372 coDiagnostiX 8 Station, and
019.0373 coDiagnositX 8 coDoctor.
|Straumann Manufacturing Inc.
60 Minuteman Rd
Andover, Massachusetts 01810-1008
|For Additional Information Contact
|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.
|DESIGN: Software Design
||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 18.104.22.16872), 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 ordered from Technical Support at 866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 am to 8:00 pm Eastern Time.
|Quantity in Commerce
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = LLZ and Original Applicant = IVS SOLUTIONS AG