FDA-Device2024-09-18Class II
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
Fresenius Medical Care Holdings, Inc.
Hazard
Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
Sold states
US Nationwide. Canada.
Affected count
3,718 systems
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3124-2024Don't want to check this manually?
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