Hemodialysis Delivery System, Software Version 2.x.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has recalled 4,248 units of its Hemodialysis Delivery System with Software Version 2.x. The systems have a software defect where, if an operator changes a prescription after switching a disposable filter using the "Same Patient" button, the system may display suggested values from the original prescription profile instead of the current prescription. This could potentially result in incorrect prescription parameters being used during therapy. The affected systems were distributed nationwide across the United States and internationally to multiple countries including Canada, Mexico, Australia, and various European nations.
The recalled units are identified by Product Code 955626 and UDI 0085412639499, with numerous lot and serial numbers ranging from 107208 through 109171. The source document does not specify a remedy or instructions for affected consumers regarding how to address this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
Reason for recall: If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription. Distribution: Distributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saud Quantity: 4248 Lot/code info: Software Version 2.x.; Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378, 107379, 107380, 107381, 107382, 107383, 107384, 107385, 107386, 107387, 107483, 107484, 107485, 107486, 107487, 107488, 107489, 107490, 107491, 107492, 107493, 107494, 107495, 107496, 107497, 107498, 107499, 107500, 107501, 107502, 107503, 107504, 107505, 107506, 107507, 107508, 107509, 107510, 107511, 107512, 107818, 107819, 107820, 107821, 107822, 107823, 107824, 107825, 107826, 107827, 107878, 107879, 107880, 107881, 107882, 107883, 107884, 107885, 107886, 107887, 108193, 108194, 108195, 108196, 108197, 108198, 108199, 108200, 108201, 108202, 108203, 108204, 108205, 108206, 108207, 108208, 108209, 108210, 108211, 108212, 108303, 108304, 108305, 108306, 108307, 108308, 108309, 108310, 108311, 108312, 108453, 108454, 108455, 108456, 108457, 108458, 108459, 108460, 108461, 108462, 108503, 108504, 108505, 108506, 108507, 108508, 108509, 108510, 108511, 108512, 108777, 108778, 108779, 108780, 108781, 108782, 108783, 108784, 108785, 108786, 108842, 108843, 108844, 108846, 108847, 108848, 108849, 108850, 108851, 100121, 103416, 103417, 103418, 103419, 103420, 103421, 103422, 103423, 103424, 103425, 108845, 108934, 108935, 108936, 108938, 108940, 108942, 108947, 108951, 108952, 108954, 108956, 108958, 109081, 109082, 109083, 109084, 109085, 109086, 109087, 109088, 109089, 109090, 109091, 109092, 109093, 109094, 109095, 109096, 109097, 109098, 109099, 109100, 109171,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.