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Class I recall Z-0123-2027: Ventec Life Systems, Inc. vs Class I recall Z-0127-2027: Ventec Life Systems, Inc.: FDAPulse comparison
Class I recall Z-0123-2027: Ventec Life Systems, Inc. (2026-10-28) and Class I recall Z-0127-2027: Ventec Life Systems, Inc. (2026-10-28) are peer FDAPulse records in Washington.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Class I recall Z-0123-2027: Ventec Life Systems, Inc. compare to Class I recall Z-0127-2027: Ventec Life Systems, Inc.?
| Field | Class I recall Z-0123-2027: Ventec Life Systems, Inc. | Class I recall Z-0127-2027: Ventec Life Systems, Inc. |
|---|---|---|
| Record | Device recall | Device recall |
| Recall number | Z-0123-2027 | Z-0127-2027 |
| Recalling firm | Ventec Life Systems, Inc. | Ventec Life Systems, Inc. |
| Classification | Class I | Class I |
| Status | Ongoing | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated | Voluntary: Firm initiated |
| Specialty | Other | Other |
| Product | VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support. | VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. 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. | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Quantity | 325 units | 100 units |
| Distribution | Distribution US nationwide including Puerto Rico. | Distribution US nationwide including Puerto Rico. |
| Recall initiated | 2026-09-17 | 2026-09-17 |
| Reported | 2026-10-28 | 2026-10-28 |
| Firm location | Bothell, WA, United States | Bothell, WA, United States |
| Predicate Speed & CAPA Advisory Opportunity Score | 82/100 | 82/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Class I recall Z-0123-2027: Ventec Life Systems, Inc. · Class I recall Z-0127-2027: Ventec Life Systems, Inc.
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