Recall Z-2081-2014 ยท IZL System, X-Ray, Mobile
AGFA Corp.
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammograph
| Date | Jul 21, 2014 (initiated Jun 6, 2014) |
| Status | Terminated |
| Reason | When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings. |
| Root cause | Use error |
| Action | Agfa Healthcare sent an "URGENT FIELD SAFETY NOTICE" dated June 6, 2014, to the US and Canadian customers. The letter described the safety alert and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was requested from the customers. Although medical staff are required to disinfect hands on a frequent basis, users must ensure that their hands are dry before using the touch screen of the DX-0100 because liquid residue may activate the action buttons on the touch screen. Customers were instructed: "Do not operate touch screen monitor with |
| Quantity | 216 units |
| Distribution | USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103597 | DX-D 100 Agfa Healthcare N.V., Jan 3, 2011 |