Recall Z-1231-2016 ยท RCE Cabinet X-Ray, Industrial
GE Inspection Technologies, LP
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
| Date | Dec 16, 2015 |
| Status | Terminated |
| Reason | GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X ray System performance standards, 21 C.F.R. 1020.40(c)(1)(i) |
| Root cause | Vendor change control |
| Action | GE Inspection Technologies Planned Action to bring into Compliance: 1. GE Inspection Technologies will use their updated adhesive procedure to install new brackets to the bottom left and right lead strips in the control door. The new procedure and brackets were developed in November 2013. 2. A second notification of customers with affected systems will be sent within 5 days of approval of this CAP. This notification will describe the repair above and propose that a GE technician visit each site and install the described repair. 3. Repairs will be completed within 120 days after approval |
| Quantity | 55 US Distribution |
| Distribution | US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.