# FDA recall Z-0883-2026

> **Philips Ultrasound, LLC** · Class II · device recall initiated 2025-10-31.

## Product

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

## Reason for recall

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

## Distribution

Worldwide   US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras	, Hungary, Iceland, India, Indonesia, Israel, 	Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.

## Key facts

- **Recall number:** Z-0883-2026
- **Recalling firm:** Philips Ultrasound, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-31
- **Report date:** 2025-12-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0883-2026

## Citation

> AI Analytics. FDA recall Z-0883-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0883-2026. Source: US FDA. Licensed CC0.

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