Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-0883-2026

Philips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005

Philips Ultrasound, LLCBothell, WA, United StatesReported Dec 10, 2025 · 7 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Lumify Diagnostic Ultrasound System models : 795005, 795161989605449841
    UDI 700884838103405
    400 affected lots
    USD21L1900US122L0603USD21L1901USD21L1722US122L1176USD21L1720US122L1175US122L1186
    +392 moreUS122L0415US122L1174USD21L1587USD21L1586USD21L1416USD21L2073USD21L1589USD21L1721US122L1177US122L1305US122L0996USD21L1588US122L1190US122L1183US122L0416US122L1671US122L0523USD21L1719US122L0522US122L1048USD21L1417US122L1856US122L1854US122L1852US122L1376US122L1310US122L0040US122L1289US122L1673US122L0602USD21L1590US122L1307USD21L2052US122L1311US122L0038US122L1309USO21L0079US122L1855USO21L0048US921L1762USO21L0046USO21L0017USO21L1376US921L1485USO21L0045US921L1331US921L1694USO21L0038USO21L0039US921L1761USO21L0040US921L1760US921L1759US921L1695US921L1609USO21L0044USO21L0078USO21L0050USO21L0015US921L1610USO21L0003USO21L0043US921L1484USO21L1495USO21L0093USO21L1374USO21L1373USO21L1755USO21L0081USO21L0119USO21L1667USO21L0579USO21L0083USD21L2046USO21L1375USO21L0042US921L1330USO21L0041US921L1693USO21L0036USO21L1753USO21L0049USO21L0037US921L1696USO21L0016USO21L0047USO21L0764USO21L0080USD21L2054USD21L0049USD21L0036USD21L0037USO21L0082USD21L2049USD21L2055USD21L2051USD21L2047USD21L2239USD21L0055USD21L2153USD21L0068US122L0037USD21L0039USD21L0053USD21L0056US622L0962USD21L0040USD21L2048USO21L0578USD21L0050USD21L0051USD21L0052USD21L0066USD21L0704USD21L0054USD21L0524US821L0816US821L0583US821L0586US821L0246US821L0585US821L0582US821L0580US821L0347US821L0587US821L0581US821L0584US821L0420US821L0473US821L0101US821L0099US821L0100US821L0098US621L2293US621L2144US721L0342US621L2051US621L1995US621L2053US621L2050US721L0807US621L2054US621L2049US721L0530US721L0406US621L2057US721L0529US621L1997US721L0404US721L0528US621L2056US721L0395US621L2058US721L0803US721L0397US721L0804US621L2055US621L2052US621L1996US721L0808US721L0403US721L0396US721L0805US721L0398US721L0405US721L0159US721L0158US721L0163US721L0162US721L0164US721L0161US721L0157US721L0331US721L0337US721L0166US721L0338US721L0170US721L0168US721L0156US721L0160US721L0351US721L0169US721L0323US721L0341US721L0171US721L0167US721L0339US721L0165US721L0334US721L0402US721L0332US721L0400US721L0346US721L0409US721L0344US721L0340US721L0343US721L0810US721L0345US721L0335US721L0399US721L0401US721L0408US721L0333US721L0336US721L0522US721L0524US721L0350US721L0596US721L0527US721L0806US721L0407US721L0809US721L0523US721L0348US721L0525US721L0597US721L0526US721L0347US721L0349US821L1106US821L1721US821L1723US821L1720US821L1728US921L0458US821L1724US821L1725US821L1180US921L1154US921L0988US821L1191US821L1181US921L1283US921L0456US921L0989US921L0457US821L1798US921L0459US821L1964US821L1192US921L0762US921L0455US821L1968US821L1960US821L1411US821L1179US821L1961US721L1057US821L0304US721L1571US721L1485US721L1109US821L0248US721L1572US821L0245US721L1570US721L1070US721L1108US721L1487US721L1068US721L1480US721L1110US721L1059US721L1069US721L1569US721L1484US721L1066US821L0247US721L1486US721L1056US721L1067US721L1065US721L1481US721L1482US721L1483US821L1959US821L1967US821L1969US821L1958US821L2180US821L2210US821L2019US821L2211US821L2181US821L2020US821L2273US821L2179USD21L1419USD21L1427USD21L1295USD21L1136USD21L0883USD21L0885USD21L1423USD21L0884USD21L1421USD21L0706USD21L0882USD21L0856USD21L1424USD21L0705USD21L1422USO21L1761USN21L0034USN21L2538USN21L2540USO21L1751USO21L1752USO21L1760USO21L1758USO21L1756USN21L0035USO21L1757USN21L2553USD21L1426USN21L2546USN21L0038USN21L2097USN21L2545USN21L2547USN21L2214USO21L1762USO21L1759USN21L2100USN21L0174USO21L1754USN21L2537USN21L2539USN21L2335USN21L1575USN21L2551USN21L2096USN21L1752USN21L2099USN21L1573USN21L2550USN21L2428USN21L2549USN21L2536USN21L0173USN21L0172USN21L2098USN21L0037USN21L0036USN21L2552USN21L2548USN21L1574USN21L2541USN21L1300USD21L0073USN21L1292USN21L1290USN21L1297USD21L0058USN21L1298USN21L1293USN21L2544USD21L0060USD21L0042USD21L0069USN21L1291USD21L0046USD21L0045USD21L0057USD21L0044USD21L0059USD21L0041USN21L2542USD21L0043USD21L0048USD21L0065USN21L1294USN21L2543USD21L0163USD21L0047USN21L1299USD21L0074US122L1187US122L1181US122L1191US122L1178US122L1226US122L1227US122L1180US122L1217US122L1221US122L1185US122L1189US122L1182US122L1179US122L1184

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls