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The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
Patient Scale may become detached, which can cause a patient to fall and result in injury.
Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)