19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
FDA Recall Z-2100-2010 · Posted 2010-07-26
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-06-30
Date Terminated2011-04-28
Product Quantity805 units
Reason for Recall
Monitor fell from the mounting bracket used to support the monitor.
Firm Action
The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM as soon as possible and return via fax at 864-421-1664.
If you have any questions about this matter, please feel free to contact me via email at [email protected] or call me at 864-421-1754.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA and countries of Puerto Rico and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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