Food, drugs, devices › Philips Ultrasound, Inc.
Device recall: Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 79
Philips Ultrasound, Inc. (Bothell, WA) initiated this device recall on 9 Oct 2023; FDA lists 2 product records under event 93218, classified Class II.
FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Philips Ultrasound, Inc. has 22 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Ultrasound, Inc., Bothell, WA.
Reason for recall
"Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image."
Distribution
"US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0283-2024 | Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234) | 83 systems | Class II | Completed | 15 Nov 2023 |
| Z-0284-2024 | Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 | 7 systems | Class II | Completed | 15 Nov 2023 |
Context
Other enforcement events for Philips Ultrasound, Inc.
All 22 events for Philips Ultrasound, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.