Faxitron BioVision 10x15Recalls & reported problems

Faxitron Bioptics, LLC · Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excisions. · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857069006012), received between Sep 6, 2021 and Sep 6, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Computer Software 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

Computer Software Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjurySep 6, 2021Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT ON (B)(6) 2021 DURING A IMAGING USING A FAXITRON OR THE IMAGES SENT TO THE PHYSICIAN USING INTELLISPACE PACS HAD A DISCREPANCY , BECAUSE OF THIS THE PHYSICIAN HAD TO EXCISE ADDITIONAL MARGINS FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED REFERRED TO USER ERROR AND SOFTWARE ERROR, A TECHNICIAN WAS ABLE TO FIX THE ISSUE FOR FUTURE TESTS AND EXPLAIN THE CUSTOMER HOW TO USE IT PROPERLY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12428634 ↗

Device details

UDI-DI	`00857069006012`
Brand	Faxitron
Model	BioVision 10x15
Company	Faxitron Bioptics, LLC
Product code	MWP · Cabinet,X-Ray System
Class	Class 2
FDA submission	K091558
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 10, 2022

Device type (GMDN): Tissue specimen x-ray system IVD

An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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