Recall Z-1745-2015 ยท IZL System, X-Ray, Mobile
AGFA Healthcare Corp.
AGFA DX-D 100 is a mobile digital radiography x-ray system
| Date | Jun 10, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. |
| Root cause | Other |
| 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 questi |
| Quantity | 233 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103597 | DX-D 100 Agfa Healthcare N.V., Jan 3, 2011 |