# Class I recall Z-0130-2027: Ventec Life Systems, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 82/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0130-2027 |
| Recalling firm | Ventec Life Systems, Inc. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | VC   Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support. |
| Reason | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Quantity | 930 units |
| Distribution | Distribution US nationwide including Puerto Rico. |
| Recall initiated | 2026-09-17 |
| Reported | 2026-10-28 |
| Firm location | Bothell, WA, United States |

## Why this score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 8 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0130-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
