Device product
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Z-0693-2024
Product summary
- Event
- Event 93648
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 195
- Official record key
device-enforcement:Z-0693-2024
Official wording
Reason: Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Code information: UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.
Distribution pattern: US: RI, CA, TX
Derived failure modes
-
Unknown
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.