CanadaBK Medical ultrasound systems are affected, including models such as Flex Focus (model 1202), bkActiv (model 2300) with specific serial/lot numbers listed, bkSpecto (model 1300), bk5000 (model 2300), and Ultrasound Scanner Systems (models BK3500 and BK3000); some affected units are identified by serial/lot numbers listed in the notice or described as “more than 10 numbers” — contact the manufacturer for specifics. They were recalled because the user guide and service manual do not adequately state required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Bk Medical Aps, Mileparken 34, Herlev, Copenhagen, Denmark, 2730.
How to identify it
Affected products: Ultrasound Scanner Flex Focus - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 1202
Affected products: bkActiv Ultrasound System; Lot or serial number: 2007497; Model or catalogue number: 2300
Affected products: bkActiv Ultrasound System; Lot or serial number: 2007609; Model or catalogue number: 2300
Affected products: bkActiv Ultrasound System; Lot or serial number: 2008878; Model or catalogue number: 2300
Affected products: bkActiv Ultrasound System; Lot or serial number: 2007478; Model or catalogue number: 2300
Affected products: bkActiv Ultrasound System; Lot or serial number: 2005278; Model or catalogue number: 2300
Affected products: bkActiv Ultrasound System; Lot or serial number: 2007610; Model or catalogue number: 2300
Affected products: bkActiv Ultrasound System; Lot or serial number: 2006358; Model or catalogue number: 2300
Affected products: bkSpecto Ultrasound System 1300; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 1300
Affected products: Ultrasound Scanner System 2300 - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: BK3500
Affected products: Ultrasound Scanner System 2300 - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: BK3000
Affected products: bk5000 Ultrasound System - Main Unit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2300
The hazard
The instructions for use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)