FDR-2000BPY POSITIONER KIT BPY-L HA USA ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410336047), received between Jul 19, 2019 and Sep 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K133972, K191495); 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2021Malposition of Device; Malposition of Device

  FUJIFILM WAS INFORMED THAT DURING A BIOPSY EXAM A NEEDLE MISPUNCTURE OCCURRED IN GERMANY. A BIOPSY ON THE PATIENT WAS PERFORMED AND THE NEEDLE DROVE TOO DEEP INTO THE PATIENT'S BREAST, PASSING THROUGH THE CALCIFICATION (Z AXIS STROKE TOO LONG). THE (VACUUM) NEEDLE PENETRATED THE CAUDAL SKIN OF THE PATIENT. THE NEEDLE WAS PULLED BACK INTO THE POSITION OF THE CALCIFICATION AND THE OPERATOR (PHYSICIAN) WAS ABLE TO EXTRACT A BIOPSY SAMPLE. THE EXAM COULD BE FINALIZED AND THE PATIENT WAS SENT HOME AFTER TREATING THE CUT WITH AN ADHESIVE BANDAGE. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT; THIS INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION. THIS EVENT WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2019. THE MANUFACTURER REPORTED THIS EVENT TO FDA UNDER REPORT # 3001722928-2019-00009.

  Patient problems: Perforation; Skin Tears

  MAUDE report 12445821 ↗
• MalfunctionJul 19, 2019Malposition of Device; Malposition of Device

  FUJIFILM WAS INFORMED THAT DURING A BIOPSY EXAM A NEEDLE MISPUNCTURE OCCURRED IN (B)(6). PROCEDURE 1, PATIENT 1: PRE-SHOTS, USED FOR CALCULATING THE LOCATION OF THE MICROCALC AND BIOPSY POSITIONER / NEEDLE POSITION, WERE PERFORMED WITHOUT PROBLEMS. AFTER THE EXPOSURES THE BIOPSY POSITIONER (THE BIOPSY ADD-ON DEVICE HOLDING AND POSITIONING THE NEEDLE) GENERATED AN ERROR MESSAGE "PROCESS COMMUNICATION NOT POSSIBLE" FOLLOWED BY ERROR MESSAGE "ERROR WHILE SAVING TARGET INFO". PATIENT 1 WAS SENT HOME, AND NO BIOPSY WAS PERFORMED. THE OPERATOR REBOOTED THE UNIT AND NO ERROR WAS VISIBLE. THE OPERATOR PERFORMED DAILY ACCURACY CHECK AFTER THE REBOOT WITHOUT ERRORS OR OTHER PROBLEMS. PROCEDURE 2, PATIENT 2: A BIOPSY ON PATIENT 2 WAS PERFORMED AND THE NEEDLE DROVE TOO DEEP INTO THE PATIENT'S BREAST, PASSING THROUGH THE CALCIFICATION (Z AXIS STROKE TOO LONG). THE (VACUUM) NEEDLE PENETRATED THE CAUDAL SKIN OF THE PATIENT. THE NEEDLE WAS PULLED BACK INTO THE POSITION OF THE CALCIFICATION AND THE OPERATOR (PHYSICIAN) WAS ABLE TO EXTRACT A BIOPSY SAMPLE. THE EXAM COULD BE FINALIZED AND THE PATIENT WAS SENT HOME AFTER TREATING THE CUT WITH AN ADHESIVE BANDAGE. THERE WAS NO DEATH ASSOCIATED WITH THI

  Patient problems: Perforation; Skin Tears; Tissue Damage

  MAUDE report 8808829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133972, K191495. One submission often covers many models, so check the product and lot details in each record.

• Z-0661-2018 · Aug 4, 2017 · Terminated
  ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full
• Z-0386-2018 · Jul 14, 2017 · Terminated
  ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digit