AGFA DX-D 100 is a mobile digital radiography x-ray system
FDA Recall Z-1745-2015 · Posted 2015-06-10
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Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeIZL
Date Initiated2015-05-29
Date Terminated2017-01-18
Product Quantity233 units
Reason for Recall
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
Firm Action
AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 29, 2015, to all affected customers. The letter was either emailed or sent via FedEx to the US customers.
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
Please distribute this information within your facility to all those who need to be aware of the notice. Please complete the feedback form as soon as possible and return it to us.
We thank you for your careful attention to this issue and your continued support. If you have any questions about this matter, please contact your local Agfa HealthCare organization: 1-877-777-2432 and please reference PR1411200006 and PR1501190003.
Root Cause
Other
Distribution Pattern
US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.
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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