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Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.