AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
FDA Recall Z-1698-2017 · Posted 2017-03-29
Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeIZL
Date Initiated2016-01-20
Date Terminated2017-04-10
Product Quantity308
Reason for Recall
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
Firm Action
AGFA Healthcare sent an On January 20,2016, an 'URGENT FIELD SAFETY NOTICE" dated January 20, 2016, to all affected customers by email or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment form to be sent back. The letter described background information and actions. Customers with questions were instructed to call 1-877-777-2432 and reference PR1405160001-VR0000288.
For questions regarding this recall call 864-421-1984.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to 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.