A-SPOT 651Recalls & reported problems

Beekley Corporation · Palpable Mass Markers, uniform low-density see-through triangle · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00815137020384), received between Oct 22, 2018 and Jun 23, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Insufficient Device Problem Information1
Material Separation1

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

InjuryJun 23, 2026Insufficient Device Problem Information
A PALPABLE MASS MARKER FELL OFF DURING A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596309 ↗
InjuryOct 22, 2018Material Separation
THE IMAGING COMPONENT OF THE A-SPOT PALPABLE MASS MARKER SEPARATED FROM THE ADHESIVE COMPONENT AND THEREFORE DID NOT SHOW UP ON THE MAMMOGRAM IMAGE. AS A RESULT, THE MAMMOGRAM WAS REPEATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7992331 ↗

Device details

UDI-DI	`00815137020384`
Brand	A-SPOT
Model	651
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 9, 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.

Other System, X-Ray, Film Marking, Radiographic devices

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3 reports
TomoSPOT 784
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2 reports
TomoSPOT 782
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
2 reports
O-SPOT 609
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
1 report
TomoSPOT 783
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
1 report
O-SPOT 791
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
1 report

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

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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