TomoSPOT 784Recalls & reported problems

Beekley Corporation · Palpable Mass Markers, low-density see-through triangle, pinch-free material · Class 1

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815137020513), received between Nov 15, 2019 and Apr 2, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Image Display Error/Artifact” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Image Display Error/Artifact1
Insufficient Device Problem Information1
Nonstandard Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Code Available1

Recent adverse event reports

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

InjuryApr 2, 2026Insufficient Device Problem Information
A SKIN MARKER FOR PALPABLE MASSES DID NOT SHOW ON A PATIENT'S MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766883 ↗
InjuryNov 15, 2019Image Display Error/Artifact; Nonstandard Device
A PALPABLE MASS MARKER CAUSED ARTIFACT ON A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.
Patient problems: No Code Available
MAUDE report 9330391 ↗

Device details

UDI-DI	`00815137020513`
Brand	TomoSPOT
Model	784
Company	Beekley Corporation
Product code	JAC · System, X-Ray, Film Marking, Radiographic
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 4, 2024

Device type (GMDN): Radiological image marker, noninvasive, single-use

A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker or clip, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a single-use device.

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All System, X-Ray, Film Marking, Radiographic devices →

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