FDA Device recall Z-0883-2026
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841
- FDA Device
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841 by Philips Ultrasound, citing ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0883-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Reason
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Identifiers
| code_info | UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901…UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901 USD21L1722 US122L1176 USD21L1720 US122L1175 US122L1186 US122L0415 US122L1174 USD21L1587 USD21L1586 USD21L1416 USD21L2073 USD21L1589 USD21L1721 US122L1177 US122L1305 US122L0996 USD21L1588 US122L1190 US122L1183 US122L0416 US122L1671 US122L0523 USD21L1719 US122L0522 US122L1048 USD21L1417 US122L1856 US122L1854 US122L1852 US122L1376 US122L1310 US122L0040 US122L1289 US122L1673 US122L0602 USD21L1590 US122L1307 USD21L2052 US122L1311 US122L0038 US122L1309 USO21L0079 US122L1855 USO21L0048 US921L1762 USO21L0046 USO21L0017 USO21L1376 US921L1485 USO21L0045 US921L1331 US921L1694 USO21L0038 USO21L0039 US921L1761 USO21L0040 US921L1760 US921L1759 US921L1695 US921L1609 USO21L0044 USO21L0078 USO21L0050 USO21L0015 US921L1610 USO21L0003 USO21L0043 US921L1484 USO21L1495 USO21L0093 USO21L1374 USO21L1373 USO21L1755 USO21L0081 USO21L0119 USO21L1667 USO21L0579 USO21L0083 USD21L2046 USO21L1375 U |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0883-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.