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.
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Allura Xper FD10/10; Model Number: 722011;
Model Number: 722011; System Product Name: Allura Xper FD10/10; UDI-DI: 00884838059047; Serial Numbers: 268, 205, 213, 89, 293, 294, 116, 272, 113, 152, 112, 139, 141, 111, 81, 66, 46, 153, 115, 114, 274;
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 →