Schiller EASY PULSE®
Brand(s)
Last updated
Summary
Product
Schiller EASY PULSE®
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| EASY PULSE® | 4000.000701 | 3.940410 |
| EASY PULSE® | 4000.000728 | 3.940410 |
| EASY PULSE® | 4000.000729 | 3.940410 |
| EASY PULSE® | 4000.000701 | 3.940409 |
| EASY PULSE® | 4000.000728 | 3.940409 |
| EASY PULSE® | 4000.000729 | 3.940409 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Schiller Ag
Altgasse 68, Baar, Zug, Switzerland, 6341
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78405
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