Events

Recall of Straumann coDiagnostiX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Straumann Manufacturing Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59797
  • Event Risk Class
    Class 2
  • Event Number
    Z-3184-2011
  • Event Initiated Date
    2011-08-04
  • Event Date Posted
    2011-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103755
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • 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.
  • 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 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.

Device

Straumann coDiagnostiX
  • Model / Serial
    Software version 8.0 as listed below: listed are the affected articles. Internet Upgrade: 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 Offline Upgrades: 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 coDlagnostiX licenses: 019.0370 coDiagnostiX 8 PPP 019.0371 coDiagnostiX 8 PPG 0'19.0372 coDiagnostiX 8 Station, and  019.0373 coDiagnositX 8 coDoctor.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer
    Straumann Manufacturing Inc.

Manufacturer

Straumann Manufacturing Inc.
  • Manufacturer Address
    Straumann Manufacturing Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Source
    USFDA