BreastBoardLX™ MBLXIRecalls & reported problems
Macromedics B.V. · BreastBoard LX™, 2P, extended cushion aperture, adjustable lower arm supports with high armcup, adjustable cranial arm supports with high armcup, bottomstop, integrated L-profile mask fixation points · Class 2
Data updated Oct 18, 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 08719425702056), received between Jul 9, 2018 and Jul 9, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Injury2
- Inflammation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2018Insufficient Device Problem Information
THREE (3) PERSONS (HEALTH-CARE PROFESSIONALS) OBTAINED CARBON FIBRE SPLINTERS IN THEIR HANDS DURING THE USE OF THE DEVICE. IN THE CASE OF ONE PERSON, THIS RESULTED IN MINOR INFLAMMATORY REACTIONS. THE INJURED PERSONS DID NOT REQUIRE ANY MEDICAL INTERVENTION.
Patient problems: Inflammation; Injury
MAUDE report 7669123 ↗InjuryJul 9, 2018Fracture; Fracture
IT WAS REPORTED THAT A RADIATION THERAPIST ENDED UP WITH 6 OR 7 CARBON FIBRE SPLINTERS IN THEIR HAND FROM USE OF THE DAMAGED DEVICE. THE SPLINTERS WERE REMOVED BY A NURSE.
Patient problems: Injury
MAUDE report 7669121 ↗
Other Accelerator, Linear, Medical devices
- LANDAUER microSTAR® ii Dosimetry SystemLandauer, Inc. · Accelerator, Linear, Medical38 recalls0 reports
- MOSAIQElekta, Inc. · Accelerator, Linear, Medical3 recalls112 reports
- Elekta Medical Linear Accelerator 1552093Elekta Solutions AB · Accelerator, linear, medical5 recalls6 reports
- Elekta Medical Linear Accelerator 1552092Elekta Solutions AB · Accelerator, linear, medical5 recalls0 reports
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 reports
- Elekta Medical Linear Accelerator 1550358Elekta Solutions AB · Accelerator, linear, medical4 recalls2 reports
- Elekta Medical Linear Accelerator 1552091Elekta Solutions AB · Accelerator, linear, medical4 recalls1 report
- Elekta Medical Linear Accelerator 1550359Elekta Solutions AB · Accelerator, linear, medical4 recalls0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page