# Class I recall Z-0152-2027: Philips Ultrasound, LLC

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0152-2027 |
| Recalling firm | Philips Ultrasound, LLC |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Philips Lumify Diagnostic Ultrasound System |
| Reason | 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 | 13,206 |
| Distribution | 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 | 2026-09-24 |
| 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-0152-2027%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.