PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →