Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Reason for recall: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery. Distribution: US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA. Quantity: 12 customers Lot/code info: LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
00887709127227
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.