CanadaSchiller EASY PULSE® devices, models 3.940410 and 3.940409 with lot/serial numbers 4000.000701, 4000.000728, and 4000.000729 are affected. A software change (version 1.1.3) reduced the piston's initial acceleration and increased sensitivity to counterforces, which can prevent piston movement at start-up and trigger a premature safety stop. Contact the manufacturer for additional information.
What's being recalled
Companies: Schiller Ag, Altgasse 68, Baar, Zug, Switzerland, 6341.
How to identify it
Affected products: EASY PULSE®; Lot or serial number: 4000.000701; Model or catalogue number: 3.940410
Affected products: EASY PULSE®; Lot or serial number: 4000.000728; Model or catalogue number: 3.940410
Affected products: EASY PULSE®; Lot or serial number: 4000.000729; Model or catalogue number: 3.940410
Affected products: EASY PULSE®; Lot or serial number: 4000.000701; Model or catalogue number: 3.940409
Affected products: EASY PULSE®; Lot or serial number: 4000.000728; Model or catalogue number: 3.940409
Affected products: EASY PULSE®; Lot or serial number: 4000.000729; Model or catalogue number: 3.940409
The hazard
The root cause has been identified as excessive counterforce applied to the piston at start-up, which prevents the piston from initiating movement. With the release of software version 1.1.3, the initial acceleration of the piston was reduced. However, this adjustment has inadvertently increased the device's sensitivity to counterforces, resulting in premature activation of the safety stop under certain conditions.
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)