Recall Z-1698-2017 ยท IZL System, X-Ray, Mobile
AGFA Healthcare Corp.
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
| Date | Mar 29, 2017 (initiated Jan 20, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 308 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103597 | DX-D 100 Agfa Healthcare N.V., Jan 3, 2011 |