Recall Z-1902-2021 ยท CBK Ventilator, Continuous, Facility Use
Ventec Life Systems, Inc.
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
| Date | Jun 21, 2021 (initiated May 10, 2021) |
| Status | Open, Classified |
| Reason | Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy. |
| Root cause | Device Design |
| Action | During the week of May 10, 2021, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter via FedEx or overnight mail to customers informing them that due to malfunctions of the Control Board there is the potential of unexpected shut downs and/or lost of ventilator blower function. As a result, the ventilators may fail to provide ventilation therapy to the patients. Customers are instructed to complete the following clinical action until a replacement unit can be provided: Follow your procedures to transfer the patient to an alternative source of ventilation, if available. If no ot |
| Quantity | 1,934 devices (415 device that have not been updated) |
| Distribution | Distribution US nationwide, Hong Kong, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162877 | VOCSN Unified Respiratory System Ventec Life Systems, Inc., Apr 7, 2017 |