bk3000, bk3500, bk5000, bkActiv 2300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704916000264), received between Aug 23, 2024 and Aug 23, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Flare or Flash” (1 report).

6 FDA recall records name this device's identifier, 6 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

1. Oct 9, 2025Class IIOpen, Classified

   GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

   Z-0438-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Oct 9, 2025Class IIOpen, Classified

   GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

   Z-0437-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. Oct 9, 2025Class IIOpen, Classified

   GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

   Z-0439-2026 · Root cause: Device Design · Recall details · FDA record ↗

4. Oct 9, 2025Class IIOpen, Classified

   GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

   Z-0440-2026 · Root cause: Device Design · Recall details · FDA record ↗

5. Sep 4, 2024Class IIOpen, Classified

   The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.

   Z-0136-2025 · Root cause: Process control · Recall details · FDA record ↗

6. Nov 30, 2023Class IIOpen, Classified

   An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

   Z-0813-2024 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Smoking; Flare or Flash; Smoking; Flare or Flash

  ACCORDING TO THE COMPLAINT, A CUSTOMER REPORTED A THERMAL EVENT ON THEIR BK3000 SYSTEM (S/N: (B)(6) ). WHILE RECHARGING IN ANOTHER ROOM ABOUT AN HOUR AFTER THE PROCEDURE, IT WAS NOTICED THAT SMOKE WAS COMING FROM THE ROOM AND A FIRE IN THE POWER SUPPLY AT THE BASE OF THE MACHINE WAS OBSERVED. UPON OBSERVATION, THE FIRE WAS EXTINGUISHED. NO HARM TO PATIENTS OR USERS HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050894 ↗