Recall Z-3245-2018 ยท KPR System, X-Ray, Stationary
Agfa N.V.
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patie
| Date | Sep 25, 2018 (initiated Aug 15, 2018) |
| Status | Terminated |
| Reason | A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others. |
| Root cause | Component design/selection |
| Action | On August 15, 2018, an "URGENT FIELD SAFETY NOTICE" letter was emailed to the US and Canadian consignees. The letter described the product issue: Breakage of the steel cables that support the equipment to its roof anchor may cause the equipment to fall down and potentially harm the patient, user, or third parties. Actions undertaken by Agfa NV: Soon Agfa NV or its representative will visit your site to do a verification/inspection of your unit related to this topic. Despite the fact that this issue potentially affects older systems with high workload, Agfa NV or its representative will verify |
| Quantity | 108 |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112670 | DX-D 600 Agfa Healthcare N.V., Oct 27, 2011 |