Recall Z-0123-2027 ยท CBK Ventilator, Continuous, Facility Use
Ventec Life Systems, Inc.
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
| Date | Oct 20, 2026 (initiated Sep 17, 2026) |
| Status | Open, Classified |
| Reason | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Root cause | Under Investigation by firm |
| Action | On September 17, 2026, Ventec Life Systems Inc. dba React Health issued a Urgent: Medical Device Recall Notification via certified mail. Ventec ask consignees to take the following actions: 1.Review the customer communication and follow the applicable Actions to be Taken section. 2. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to React Health via email, mail or use the online customer response form within 7 days. 3. If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify |
| Quantity | 325 units |
| Distribution | Distribution US nationwide including Puerto Rico. |
| 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 |