CLASS II Device recall · Reported 22 Aug 2018 · FDA Enforcement Report

Mevion S250/Mevion S250i Proton Beam Radiation therapy system recalled

Mevion Medical Systems is recalling Mevion S250/Mevion S250i Proton Beam Radiation therapy system, distributed nationwide in the US. The recall was initiated on 29 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesS250-0001 through S250-0006 and S250i-0007

Quantity recalled7

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2746-2018
FDA event ID: 80615
Recalling firm: Mevion Medical Systems, Littleton, MA
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2018
FDA classified: 10 Aug 2018
Reported: 22 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Jun 2018	Recall initiated by company
10 Aug 2018	Classified by FDA	+42 days
22 Aug 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

Where it was distributed

US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.

Nationwide District of Columbia Florida Missouri New Jersey Ohio Oklahoma

Questions about this recall

Why was it recalled?

Which lots are affected?

S250-0001 through S250-0006 and S250i-0007

Where was it sold?

US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mevion Medical Systems

All 14

Reported	Class	Recall	Company	Reason	Where
6 Apr 2022Device	CLASS II	Mevion S250 and S250i Proton Therapy Systems hand pendant recalled	Mevion Medical Systems	Device Malfunction	Nationwide
2 Dec 2020Device	CLASS II	Mevion S250i, Mevion S250 recalled by Mevion Medical Systems	Mevion Medical Systems	Other	Nationwide
29 Jul 2020Device	CLASS II	Mevion S250 Proton Radiation Treatment System recalled	Mevion Medical Systems	Other	6 states
1 Jul 2020Device	CLASS II	Mevion S250i, Mevion S250 recalled by Mevion Medical Systems	Mevion Medical Systems	Other	6 states
16 Jan 2019Device	CLASS II	Mevion S250i recalled by Mevion Medical Systems	Mevion Medical Systems	Other	DC

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