Recall archive / FDA device enforcement
S4-1 Transducer Probe — FDA record Z-2391-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- S4-1 Transducer Probe
- Reason
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Classification
- Class III
- Recalling firm
- Philips Ultrasound, Inc
- Quantity
- 171,322 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2391-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. 989605389271, 989605389272, 989605364993; UDI: (01)00884838061415(21)B30VBN, (01)00884838061415(21)F0954W, (01)00884838061415(21)B3WCRT, (01)00884838061415(21)B1WDKX, (01)00884838061415(21)B1WDNQ, (01)00884838064584(21)B13HXX, (01)00884838064584(21)B1MQDX, (01)00884838064584(21)B23LRM, (01)00884838064584(21)B23LRT, (01)00884838061415(21)B1X9Z3, (01)00884838064584(21)B12QQ8, (01)00884838061415(21)B27XB2, (01)00884838061415(21)B307TT, 010088483806141521F01WFB, (01)00884838061415(21)B30THD, (01)00884838061415(21)B1TKB3, (01)00884838061415(21)F08XDL, (01)00884838061415(21)F0B7L5, (01)00884838061415(21)F048QQ, (01)00884838061415(21)F0665R; Serial No. B30VBN, B1GPT4, B1NW75, F0954W, B3WCRT, B1WDKX, B1WDNQ, B13HXX, B1MQDX, B23LRM, B23LRT, B1X9Z3, B12QQ8, B27XB2, B307TT, F01WFB, B1KXRP, B30THD, B1TKB3, F08XDL, F0B7L5, F048QQ, F0665R. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 3, 2025
- Center classification date
- Aug 22, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.