Transducer S8-3t 989605431171Recalls & reported problems
Philips Ultrasound LLC · Class 2
All models of Transducer S8-3t (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00884838073524), received between Apr 30, 2019 and Nov 20, 2020 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (10 reports).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 3, 2025Class IIIOpen, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-2398-2025 · Root cause: Device Design · Recall details · FDA record ↗
- May 28, 2025Class IIOpen, Classified
Ultrasound transducer devices were refurbished beyond their useful life.
Z-2061-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Poor Quality Image10
- No Display/Image2
- Defective Component1
- Device Displays Incorrect Message1
- Display Difficult to Read1
- Image Display Error/Artifact1
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient8
- No Patient Involvement1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2020Mechanical Problem; Mechanical Jam; No Apparent Adverse Event; Mechanical Problem; Mechanical Jam; No Apparent Adverse Event
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10876585 ↗MalfunctionAug 10, 2020Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10388397 ↗MalfunctionJul 28, 2020Therapeutic or Diagnostic Output Failure
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10333699 ↗MalfunctionJul 23, 2020Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10314218 ↗MalfunctionJul 16, 2020Image Display Error/Artifact
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING IMAGE ARTIFACTS. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10286335 ↗MalfunctionJul 10, 2020No Display/Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING NO IMAGES. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10257672 ↗MalfunctionJun 29, 2020Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10209753 ↗MalfunctionJun 3, 2020Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10116392 ↗MalfunctionApr 13, 2020Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9955380 ↗MalfunctionMar 18, 2020Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9849883 ↗MalfunctionDec 17, 2019Poor Quality Image; Device Displays Incorrect Message
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS DISPLAYING AN OVERHEATING ERROR MESSAGE AND PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9483729 ↗MalfunctionDec 9, 2019Defective Component
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9438947 ↗MalfunctionNov 12, 2019Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9310140 ↗MalfunctionOct 1, 2019Display Difficult to Read
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS NOT DISPLAYING IMAGES PROPERLY DUE TO NO ARTICULATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9142038 ↗MalfunctionJul 30, 2019Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY DUE TO COLOR NOISE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8841572 ↗MalfunctionJun 18, 2019No Display/Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS NOT PRODUCING IMAGES. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8709365 ↗MalfunctionApr 30, 2019Poor Quality Image
A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8567159 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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