ProductGuru Recalls

Official recall record

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

US FDA — Medical Devices · 2025-12-10 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2025-12-10
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
07340201500026
Brand on record
Elekta, Inc.

What the authority reported

Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

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