Recall Z-0883-2026 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, LLC
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
| Date | Dec 4, 2025 (initiated Oct 31, 2025) |
| Status | Open, Classified |
| Reason | Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 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, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Arm |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203406 | Lumify Diagnostic Ultrasound System Philips Ultrasound, Inc., Feb 23, 2021 |
| K223771 | Lumify Diagnostic Ultrasound System Philips Ultrasound, May 4, 2023 |
| K232500 | Lumify Diagnostic Ultrasound System Philips Ultrasound, Oct 26, 2023 |
| K242519 | Lumify Diagnostic Ultrasound System Philips Ultrasound, May 15, 2025 |
| K242670 | Lumify Diagnostic Ultrasound System Philips Ultrasound, May 8, 2025 |