Z-1196-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2025
- Initiation Date
- February 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
Product Description
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Reason for Recall
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
Distribution Pattern
US distribution in CA, NY, and MO.
Code Information
REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627, 121892, 119639; PRT-01185-000/00855573007877/5038421, 116700, 117933, 5038112, 5038619, 5038717, 5038953, 5039086, 5039091, 5039361, 5039499, 5039503, 5039541, 5039636, 5039938, 5040019, 5040640, 5040762, 5041060, 5041078, 5041534, 5042558, 117344, 118464, 118509, 5039387; PRT-01185-002/00850018761154/5037655