ASPIRE Cristalle DR 3500 W 24X30 USA + ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547410297546), received between Nov 7, 2018 and Mar 26, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K133972, K173132, K212873); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 11, 2025Class IIOpen, Classified

   Devices had an unapproved slabbing software function enabled for use.

   Z-2219-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 26, 2024Patient Data Problem; Patient Data Problem

  ON 4TH MARCH 2024, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING DR 3500 W 24X30 USA E. IT WAS REPORTED THAT THE DEVICE IS UNABLE TO SEPARATE CASES IN THE MAMMO UNIT, IT KEEPS MIXING UP THE PATIENT'S INFORMATION THAT DO NOT MATCH THE CORRECT PATIENT. THERE IS NO PATIENT HARM OR INJURY REPORTED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18983478 ↗
• MalfunctionFeb 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTS THAT SCREENINGS CONDUCTED WITH THE ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS (DBT) OPTION MAY BE GENERATING LOWER PATIENT RECALL RATES AT THEIR HEALTHCARE FACILITY THAN EXPECTED. WHILE THE ASPIRE CRISTALLE PRODUCT IS FUNCTIONING TO SPECIFICATIONS, FURTHER REVIEW IS BEING CONDUCTED. THERE IS NO KNOWN DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378403 ↗
• MalfunctionFeb 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTS THAT SCREENINGS CONDUCTED WITH THE ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS (DBT) OPTION MAY BE GENERATING LOWER PATIENT RECALL RATES AT THEIR HEALTHCARE FACILITY THAN EXPECTED. WHILE THE ASPIRE CRISTALLE PRODUCT IS FUNCTIONING TO SPECIFICATIONS, FURTHER REVIEW IS BEING CONDUCTED. THERE IS NO KNOWN DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378399 ↗
• InjuryNov 7, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN INJURY OCCURRED DURING AN EXAM BEING PERFORMED WITH AN ASPIRE CRISTALLE. THE PATIENT WITH MULTIPLE SCLEROSIS WHO WAS AN INVALID AND COULD NOT USE THEIR HANDS WAS SEATED IN A BIOPSY CHAIR. THE PRIMARY MAMMOGRAPHER PRESSED THE "ONE TOUCH" BUTTON TO MOVE THE GANTRY TO THE HOME POSITION, AT THIS TIME THE ASSISTING MAMMOGRAPHER HAD THEIR HAND BETWEEN THE CHAIR AND THE MOVING TUBE ARM. THE MOVING TUBE ARM HIT THE CHAIR AND THE ASSISTING MAMMOGRAPHER'S HAND IN BETWEEN; THE TUBE ARM BENDED WHEN IT HIT THE CHAIR AND ASSISTING MAMMOGRAPHER. THE ASSISTING MAMMOGRAPHER CONTINUED WORKING UNTIL THE NEXT DAY, HOWEVER THEN THE MAMMOGRAPHER (ASSISTING) STARTED FEELING PAIN AND WENT TO URGENT CARE; THE HAND WAS BLACK AND BLUE. AFTER FURTHER FOLLOW UP WITH THE ASSISTING MAMMOGRAPHER, IT WAS FOUND THAT AN X-RAY WAS PERFORMED FOR THE INJURED HAND AND THERE WERE NO BONE BREAKS; SEVERAL DAYS LATER THE BRUISING WENT DOWN AND THE HAND WAS BACK TO NORMAL. THERE WAS NO MALFUNCTION OF THE DEVICE. THERE WAS NO ADVERSE EVENT OR INJURY TO THE PRIMARY MAMMOGRAPHER OR THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Bruise/Contusion

  MAUDE report 8046224 ↗
• InjuryNov 7, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN INJURY OCCURRED DURING AN EXAM BEING PERFORMED WITH AN ASPIRE CRISTALLE. THE PATIENT WITH MULTIPLE SCLEROSIS WHO WAS AN INVALID AND COULD NOT USE THEIR HANDS WAS SEATED IN A BIOPSY CHAIR. THE PRIMARY MAMMOGRAPHER PRESSED THE "ONE TOUCH" BUTTON TO MOVE THE GANTRY TO THE HOME POSITION, AT THIS TIME THE ASSISTING MAMMOGRAPHER HAD THEIR HAND BETWEEN THE CHAIR AND THE MOVING TUBE ARM. THE MOVING TUBE ARM HIT THE CHAIR AND THE ASSISTING MAMMOGRAPHER'S HAND IN BETWEEN; THE TUBE ARM BENDED WHEN IT HIT THE CHAIR AND ASSISTING MAMMOGRAPHER. THE ASSISTING MAMMOGRAPHER CONTINUED WORKING UNTIL THE NEXT DAY; HOWEVER, THEN THE MAMMOGRAPHER (ASSISTING) STARTED FEELING PAIN AND WENT TO URGENT CARE. THE HAND WAS BLACK AND BLUE. AFTER FURTHER FOLLOW UP WITH THE ASSISTING MAMMOGRAPHER, IT WAS FOUND THAT AN X-RAY WAS PERFORMED FOR THE INJURED HAND AND THERE WERE NO BONE BREAKS; SEVERAL DAYS LATER THE BRUISING WENT DOWN AND THE HAND WAS BACK TO NORMAL. THERE WAS NO MALFUNCTION OF THE DEVICE. THERE WAS NO ADVERSE EVENT OR INJURY TO THE PRIMARY MAMMOGRAPHER OR THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Bruise/Contusion

  MAUDE report 8046195 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133972, K173132, K212873. 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