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Class I recall Z-0122-2027: Ventec Life Systems, Inc. vs Class I recall Z-0152-2027: Philips Ultrasound, LLC: FDAPulse comparison
Class I recall Z-0122-2027: Ventec Life Systems, Inc. (2026-10-28) and Class I recall Z-0152-2027: Philips Ultrasound, LLC (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-0122-2027: Ventec Life Systems, Inc. compare to Class I recall Z-0152-2027: Philips Ultrasound, LLC?
| Field | Class I recall Z-0122-2027: Ventec Life Systems, Inc. | Class I recall Z-0152-2027: Philips Ultrasound, LLC |
|---|---|---|
| Record | Device recall | Device recall |
| Recall number | Z-0122-2027 | Z-0152-2027 |
| Recalling firm | Ventec Life Systems, Inc. | Philips Ultrasound, LLC |
| Classification | Class I | Class I |
| Status | Ongoing | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated | Voluntary: Firm initiated |
| Specialty | Other | Other |
| Product | VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. | Philips Lumify Diagnostic Ultrasound System |
| Reason | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. | Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay. |
| Quantity | 4,369 units | 13,206 |
| Distribution | Distribution US nationwide including Puerto Rico. | Worldwide - US Nationwide distribution including in the states of CA, MA, IL, NY, OR, GA, TX, WA, FL, PA, WI, LA, NJ, KY, VA, MS, AZ, SC, CT, MN, UT, OH, AL, MI, NH, MO, TN, IN, DC, NE, NM, MT, NV, NC, MD, IA, SD, VT, KS, AK, CO, ID, OK, WV, AR, RI, ME, WY, HI, DE, ND and the countries of CA, NO, HR |
| Recall initiated | 2026-09-17 | 2026-09-24 |
| 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-0122-2027: Ventec Life Systems, Inc. · Class I recall Z-0152-2027: Philips Ultrasound, LLC
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