Prismaflex Control Units
Brand(s)
Last updated
Summary
Product
Prismaflex Control Units
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 |
|---|---|---|
| Prismaflex ST100 Sets | All lots. | 107636 |
| Oxiris Set Row | All lots. | 973003 |
| Prismaflex HF1000 Set | All lots. | PRISMAFLEX HF1000 |
| Prismaflex HF1000 Set | All lots. | 107140 |
| Prismaflex ST150 Set | All lots. | PRISMAFLEX ST150 SET |
| Prismaflex ST150 Set | All lots. | 107640 |
| Prismaflex TPE 2000 Set | All lots. | 107144 |
| Prismaflex TPE 2000 Set | All lots. | PRISMAFLEX TPE 2000 |
Issue
Vantive is issuing an urgent medical device correction to all Prismaflex control unit users due to the potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex control unit, as shown in figure 3 below. This issue does not affect PrisMax control units and may occur only when the Prismaflex sets are being used with the Prismaflex control unit, as the two machines have different deaeration chamber holder designs.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
| Vantive Health Gmbh |
| Thurgauerstrasse 130, Glattpark (Opfikon), Switzerland, 8152 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81505
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