Food, drugs, devices › Philips Ultrasound, Inc
Device recall: Philips 3D6-2 Ultrasound Transducer
Philips Ultrasound, Inc (Reedsville, PA) initiated this device recall on 5 Sep 2025; FDA lists 11 product records under event 97643, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 2% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. 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, Reedsville, PA.
Reason for recall
"To provide clarification and labelling to define the useful life of ultrasound transducers in the field."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1618-2026 | Philips 3D6-2 Ultrasound Transducer | 17 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1619-2026 | Philips C9-4 Ultrasound Transducer | 1 unit | Class III | Ongoing | 1 Apr 2026 |
| Z-1620-2026 | Philips L12-5 Ultrasound Transducer | 40 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1621-2026 | Philips L17-5 Ultrasound Transducer | 2 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1622-2026 | Philips Mini Multi TEE Ultrasound Transducer | 11 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1623-2026 | Philips OMNI II TEE Ultrasound Transducer | 2 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1624-2026 | Philips OMNI III TEE Ultrasound Transducer | 75 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1625-2026 | Philips S4-1 Ultrasound Transducer | 41 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1626-2026 | Philips S5-2 Ultrasound Transducer | 1 unit | Class III | Ongoing | 1 Apr 2026 |
| Z-1627-2026 | Philips X3-1 Ultrasound Transducer | 17 units | Class III | Ongoing | 1 Apr 2026 |
| Z-1628-2026 | Philips X7-2 Ultrasound Transducer | 5 units | Class III | Ongoing | 1 Apr 2026 |
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: "To provide clarification and labelling to define the useful life of ultrasound transducers in the field."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.