Device product
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Z-0759-2019
Product summary
- Event
- Event 81755
- Status
- Terminated
- Classification
- Class II
- Quantity
- 821
- Official record key
device-enforcement:Z-0759-2019
Official wording
Reason: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Code information: Serial Numbers: E22000 to E23999
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Derived failure modes
-
Unknown
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn