Device Recall Phoenix micromelx and nanomelx cabinet xray systems 의 리콜

Recall

73364

Class 2

Z-1231-2016

2015-12-16

Terminated

United States

2016-10-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143968

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).

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 of this CAP and will be made free of charge. For further questions, please call (717) 447-1278. ;