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Discovery WiRecalls & reported problems

Hologic, Inc. · The Discovery series bone densitometers are computer-assisted X-Ray scanners used to aid a physician in measuring bone mineral density (BMD) and determining fracture risk. All Discovery Series densitometers allow comparison of estimated BMD from a subject's proximal femur (hip), lumbar spine, and forearm to reference data for sex and ethnicity matched controls. Discovery Wi, W, and A models can also be used for estimating the lean body mass and fat mass of non-osseous tissues. Discovery C, W, SL, and A models can be used for performing a visual or quantitative assessment of vertebral bodies for diagnosis of vertebral deformity. Discovery SL and A models are capable of measuring the lateral vertebral BMD in the supine lateral position. · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045505889), received between Jan 13, 2021 and Mar 7, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K023398); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Twisted/Bent2
  • Inability to Irrigate1
  • Material Deformation1
  • Material Fragmentation1

Patient problems

  • Pain3
  • Hematoma1
  • Needle Stick/Puncture1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 7, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT DURING A BIOPSY THE RADIOLOGIST COULD FEEL EXTRA PRESSURE WHEN INSERTING THE NEEDLE INTO THE "WHITE PORTION THAT HAS THE NUMBERS ON IT." THE RED STOPPER ON THE END CAME OFF AND WAS STUCK IN THE MIDDLE OF THE NEEDLE. THE RADIOLOGIST WAS NICKED BY THE TIP WHEN TRYING TO REMOVE THE STOPPER AND WAS SEEN BY HEALTH SERVICES. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Patient problems: Needle Stick/Puncture

    MAUDE report 11426462 ↗
  • MalfunctionMar 4, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, A SAMPLE WASN'T ABLE TO BE COLLECTED AND THE NEEDLE WAS STUCK IN THE PATIENT BREAST. WHEN THE NEEDLE WAS REMOVED FROM THE BREAST IT WAS NOTED THAT THE SHEATH WAS COMPLETELY WRINKLED. THE PATIENT HAD PAIN WHILE REMOVING THE NEEDLE, NO INJURY REPORTED.

    Patient problems: Pain

    MAUDE report 11417840 ↗
  • MalfunctionFeb 5, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, FOLLOWING LAVAGE THE PROBE WAS ROTATED TO HELP COLLAPSE THE CAVITY AND THE PATIENT COMPLAINED OF PAIN. THE NEEDLE WAS SEEN TO BE BENT ON SUBSEQUENT IMAGES.

    Patient problems: Pain

    MAUDE report 11289758 ↗
  • MalfunctionFeb 5, 2021Inability to Irrigate; Inability to Irrigate

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONFIRMED THAT THE BIOPSY WAS COMPLETED WITH SOME DISCOMFORT TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Patient problems: Hematoma; Pain

    MAUDE report 11289755 ↗
  • MalfunctionJan 13, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE AFTER THE DEVICE WAS INSERTED INTO THE PATIENT BREAST IT WAS NOTED TO BE BENT. NO INJURY REPORTED. THE DEVICE WAS REMOVED AND A SECOND DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE BIOPSY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11167232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023398. One submission often covers many models, so check the product and lot details in each record.

  • Z-2373-2024 · Jun 13, 2024 · Open, Classified
    Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN

Other Densitometer, bone devices

All Densitometer, bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.