Philips Ultrasound, LLC Lumify Diagnostic recall: Ultrasound system compatibility issues with Apple devices running iOS 18
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0883-2026
- Published
- December 10, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Philips Ultrasound, LLC
- Product type
- Medical devices
- Units affected
- 4,819 systems
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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 USO21L0042 US921L1330 USO21L0041 US921L1693 USO21L0036 USO21L1753 USO21L0049 USO21L0037 US921L1696 USO21L0016 USO21L0047 USO21L0764 USO21L0080 USD21L2054 USD21L0049 USD21L0036 USD21L0037 USO21L0082 USD21L2049 USD21L2055 USD21L2051 USD21L2047 USD21L2239 USD21L0055 USD21L2153 USD21L0068 US122L0037 USD21L0039 USD21L0053 USD21L0056 US622L0962 USD21L0040 USD21L2048 USO21L0578 USD21L0050 USD21L0051 USD21L0052 USD21L0066 USD21L0704 USD21L0054 USD21L0524 US821L0816 US821L0583 US821L0586 US821L0246 US821L0585 US821L0582 US821L0580 US821L0347 US821L0587 US821L0581 US821L0584 US821L0420 US821L0473 US821L0101 US821L0099 US821L0100 US821L0098 US621L2293 US621L2144 US721L0342 US621L2051 US621L1995 US621L2053 US621L2050 US721L0807 US621L2054 US621L2049 US721L0530 US721L0406 US621L2057 US721L0529 US621L1997 US721L0404 US721L0528 US621L2056 US721L0395 US621L2058 US721L0803 US721L0397 US721L0804 US621L2055 US621L2052 US621L1996 US721L0808 US721L0403 US721L0396 US721L0805 US721L0398 US721L0405 US721L0159 US721L0158 US721L0163 US721L0162 US721L0164 US721L0161 US721L0157 US721L0331 US721L0337 US721L0166 US721L0338 US721L0170 US721L0168 US721L0156 US721L0160 US721L0351 US721L0169 US721L0323 US721L0341 US721L0171 US721L0167 US721L0339 US721L0165 US721L0334 US721L0402 US721L0332 US721L0400 US721L0346 US721L0409 US721L0344 US721L0340 US721L0343 US721L0810 US721L0345 US721L0335 US721L0399 US721L0401 US721L0408 US721L0333 US721L0336 US721L0522 US721L0524 US721L0350 US721L0596 US721L0527 US721L0806 US721L0407 US721L0809 US721L0523 US721L0348 US721L0525 US721L0597 US721L0526 US721L0347 US721L0349 US821L1106 US821L1721 US821L1723 US821L1720 US821L1728 US921L0458 US821L1724 US821L1725 US821L1180 US921L1154 US921L0988 US821L1191 US821L1181 US921L1283 US921L0456 US921L0989 US921L0457 US821L1798 US921L0459 US821L1964 US821L1192 US921L0762 US921L0455 US821L1968 US821L1960 US821L1411 US821L1179 US821L1961 US721L1057 US821L0304 US721L1571 US721L1485 US721L1109 US821L0248 US721L1572 US821L0245 US721L1570 US721L1070 US721L1108 US721L1487 US721L1068 US721L1480 US721L1110 US721L1059 US721L1069 US721L1569 US721L1484 US721L1066 US821L0247 US721L1486 US721L1056 US721L1067 US721L1065 US721L1481 US721L1482 US721L1483 US821L1959 US821L1967 US821L1969 US821L1958 US821L2180 US821L2210 US821L2019 US821L2211 US821L2181 US821L2020 US821L2273 US821L2179 USD21L1419 USD21L1427 USD21L1295 USD21L1136 USD21L0883 USD21L0885 USD21L1423 USD21L0884 USD21L1421 USD21L0706 USD21L0882 USD21L0856 USD21L1424 USD21L0705 USD21L1422 USO21L1761 USN21L0034 USN21L2538 USN21L2540 USO21L1751 USO21L1752 USO21L1760 USO21L1758 USO21L1756 USN21L0035 USO21L1757 USN21L2553 USD21L1426 USN21L2546 USN21L0038 USN21L2097 USN21L2545 USN21L2547 USN21L2214 USO21L1762 USO21L1759 USN21L2100 USN21L0174 USO21L1754 USN21L2537 USN21L2539 USN21L2335 USN21L1575 USN21L2551 USN21L2096 USN21L1752 USN21L2099 USN21L1573 USN21L2550 USN21L2428 USN21L2549 USN21L2536 USN21L0173 USN21L0172 USN21L2098 USN21L0037 USN21L0036 USN21L2552 USN21L2548 USN21L15…
- UPC codes
- 989605449841, 00884838120266, 00884838064713, 00884838108455
Products covered by this recall
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Check your product
The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 989605449841
- 00884838120266
- 00884838064713
- 00884838108455
Model or item number
On the rating label, the box or the instruction sheet.
- 795005
- 795161
- 989605449841
- UDI
Serial number
On the rating plate, often next to the date of manufacture.
- USD21L1900 US122L0603 USD21L1901 USD21L17
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Philips Ultrasound, LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Philips Ultrasound, LLC — 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Philips Ultrasound, LLC medical devices recalled?
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 989605449841, 00884838120266, 00884838064713; model number 795005, 795161, 989605449841. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
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