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

FDA device recall Z-0883-2026 · posted 2025-12-04 · Open, Classified

Recall details

Recalling firm

Philips Ultrasound, LLC

Reason for recall

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

Action taken

On November 1, 2025, Philips issues an Urgent Medical Device Recall (Correction) Notification to affected consignees. Phillips ask consignees to take the following actions: 1. Utilize an Android based device with your Lumify system. 2. Lightning port devices are not affected and may continue to be used as normal. 3. If you use an 05 based device, do not update your OS device to software version lax. 4. Turn off 05 auto-updates on USB host devices for Lumify by following the below steps: 5. Place this Notice with the documentation of the affected Ultrasound system(s); ensure the notice is in a place likely to be viewed by device operators. 6. Circulate this Notice to all users of the affected device(s) so that they are aware of the issue. 7. Complete the Acknowledgment form indicating you have read and understand the recall.

Root cause

Software design

Status

Open, Classified

Product code

IYN

Quantity affected

4,819 systems

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,

Date initiated

2025-10-31

Date posted

2025-12-04

Location

Bothell, WA

Related 510(k) clearances