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Flex Focus Ultrasound System 1202Recalls & reported problems

Bk Medical Aps · Ultrasound scanner 1202 and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704916001025), received between Dec 20, 2017 and Dec 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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.

Most reported problems

Device problems

  • Battery Problem1
  • Fire1
  • Noise, Audible1
  • Smoking1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionDec 20, 2017Fire; Smoking; Battery Problem; Noise, Audible

    IN THE OR DURING A ROBOTIC SURGERY CASE WITH THE USE OF THE BK MEDICAL ULTRASOUND SYSTEM AT APPROXIMATELY 10:30 AM, WITH THE ULTRASOUND PLUGGED INTO THE WALL, A NURSE NOTICED A NOISE AND SAW SMOKE COMING FROM THE BACK OF FLEX FOCUS 800 ULTRASOUND S/N (B)(4) WITH UA1214 KEYBOARD STAND S/N (B)(4). THE ORDERLY IMMEDIATELY UNPLUGGED THE UNIT FROM THE WALL AND BROUGHT INTO THE HALLWAY. AT THIS TIME, THE UNIT WAS STILL SMOKING AND THE ORDERLY USED A WATER FIRE EXTINGUISHER ON THE ULTRASOUND CONCENTRATING ON THE BATTERY BAY AREA ON THE UA1214. NEXT A FIRE ALARM WAS PULLED AND THE BIO-MED TECH SHOWED UP WITH A REPLACEMENT FLEX 800. THE BIO-MED TECH SAW THE BATTERIES CATCH FIRE WHEN THE WATER WAS APPLIED. THE FIRE DID GO OUT AFTER A SHORT TIME. WHEN THE FIRE DEPT. SHOWED UP THE FIRE WAS OUT. THEY REMOVED THE EQUIPMENT AND BROUGHT IT DOWN TO THE BIO-MED SHOP. THE BIO-MED ENGINEER DID NOT KNOW THE STATUS OF THE CHARGE BEFORE INCIDENT. THEY DID SAY THE NURSES SAW THE WARNING TO REPLACE THE BATTERIES ON THE SCREEN. THE BIOMED DEPARTMENT HAD JUST ORDERED 6 NEW BATTERIES TO REPLACE ON ALL 3 ULTRASOUNDS BUT DID NOT HAVE A CHANCE TO REPLACE ON THIS UNIT YET. THEY WERE NOT AWARE THERE WERE 4 BATTERI

    Patient problems: No Information

    MAUDE report 7133582 ↗

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Sources and updates

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