Prismaflex Control Units
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
| Vantive Health Gmbh |
| Thurgauerstrasse 130, Glattpark (Opfikon), Switzerland, 8152 |
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