Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
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Product Description
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 || Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.
Model Number: 526000-03, 526000-04, 526000-07, 526000-08, 526000-09, 526000-10 Serial Number: Devices with software V1.099 manufactured from Sep 26, 2014 through Dec 20, 2016 Range of affected serial numbers: 1400028031 to 1600048470
526000-03, 526000-04, 526000-07, 526000-08, 526000-09, 526000-10;n/a | / | Devices with software V1.099 manufactured from Sep 26, 2014 through Dec 20, 2016 Range of affected serial numbers: 1400028031 to 1600048470 | 1.099