Device recall: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Class II FDA enforcement event 97843. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Philips Ultrasound, LLC started this device recall on 31 Oct 2025. The firm address in the FDA record is in Bothell, WA. FDA put the recall in Class II. FDA event 97843 has 1 product record. The first FDA enforcement report date is 10 Dec 2025. The record gives the status Ongoing. 352 of the 945 device events that started in 2025 have more product records. The median device event of 2025 has 1 product record. The openFDA file has 945 device events that started in 2025 and 972 that started in 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
Philips Ultrasound, LLC, Bothell, WA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0883-2026 | Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, | 4,819 systems | Class II | Ongoing | 10 Dec 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Sep 2026 | Philips Lumify Diagnostic Ultrasound System | Device | Class I | 1 |
| 7 Aug 2026 | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 | Device | Class II | 1 |
| 14 Jul 2022 | Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0883-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 97843. https://recallregister.com/fda/ii/97843/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 3 Nov 2026
- Newest FDA report date on the register
- 28 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 97843?
- The FDA record gives this quantity:
4,819 systems
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.