MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatm...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2746-2018.
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2746-2018.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2746-2018.
Mevion Medical Systems, Inc.
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Mevion Medical Systems, Inc. Recall FAQ
Mevion Medical Systems, Inc. is the subject of a medical devices safety report: MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatm.... The notice was published on June 29, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 7 units are potentially affected.