O-SPOT 609Recalls & reported problems

Beekley Corporation · Mole Markers, 1.6mm semi-radiolucent ring · Class 1

Data updated Oct 13, 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 00815137020346), received between May 20, 2024 and May 20, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1

Patient problems

Unintended Radiation Exposure1

Recent adverse event reports

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

InjuryMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A MOLE MARKER FELL OFF A PATIENT DURING A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.
Patient problems: Unintended Radiation Exposure
MAUDE report 19354624 ↗

Device details

UDI-DI	`00815137020346`
Brand	O-SPOT
Model	609
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 16, 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

CT-SPOT 118
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
3 reports
A-SPOT 651
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
2 reports
TomoSPOT 784
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
2 reports
TomoSPOT 782
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
2 reports
O-SPOT 791
Beekley Corporation · System, X-Ray, Film Marking, Radiographic
1 report
TomoSPOT 783
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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page