Recall Monitor
Health Products

Schiller EASY PULSE®

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Schiller EASY PULSE®
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
EASY PULSE®4000.0007013.940410
EASY PULSE®4000.0007283.940410
EASY PULSE®4000.0007293.940410
EASY PULSE®4000.0007013.940409
EASY PULSE®4000.0007283.940409
EASY PULSE®4000.0007293.940409

Issue

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.

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