Z-2100-2010

19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography...

Name: Z-2100-2010 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography...
Creator: AGFA Corp.
Published: 2010-06-30
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2010-06-30 / Terminated

FDA source

AGFA Corp. began a recall of 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... on 2010-06-30. The reason FDA records is "Monitor fell from the mounting bracket used to support the monitor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2100-2010
Status: Terminated
Initiated: 2010-06-30
Posted: 2010-07-26
Terminated: 2011-04-28
Recalling firm: AGFA Healthcare Corp.
Product: 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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Monitor fell from the mounting bracket used to support the monitor.
FDA root cause: Other
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.
Quantity in commerce: 805 units
Distribution: Worldwide distribution: USA and countries of Puerto Rico and Canada.
Product codes and lots: LU8QJ000

Product code MQB

K071162Class IIAgfa Computed Radiography System with Nx2.x WorkstationsAgfa Healthcare Corp. / cleared 2007-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)