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Mevion Medical Systems, Inc.

Mevion Medical Systems, Inc. Recalls

All product recalls associated with Mevion Medical Systems, Inc..

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1241–1260 of 3680 recalls

Mevion Proton Therapy System (Mevion) – Hand Pendant Malfunction (2022)

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

Moderate

FDAFeb 1, 2022Nationwide• Mevion Medical Systems, Inc.

INFX-8000V (Canon Medical) – Fluoroscopic Dose Rate (2022)

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.

Low

FDAJan 31, 2022Nationwide• Canon Medical System, USA, INC.

BenchMark Ultra Instruments (Ventana) – Fluid Leak Risk (2022)

Fire/Burn Risk

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

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High

FDAJan 20, 2022AL, AK, AZ +49 more• Ventana Medical Systems Inc

Biolox Delta Ceramic Femoral Head (Howmedica) – Size Labeling Error (2022)

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

Low

FDAJan 14, 2022Nationwide• Howmedica Osteonics Corp.

Volta Power System Adaptor Harness (Volta) – Wiring Defect (2022)

Fire/Burn Risk

Volta Power Systems LLC (Volta) is recalling certain adaptor harnesses, part number 100001146. The wire harness may have been built incorrectly, resulting in the loss of over-current protection.

High

NHTSAJan 13, 2022Nationwide• VOLTA POWER SYSTEM

SonialVision G4 X-Ray System (Shimadzu) – Radiation Dose Issue (2022)

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

High

FDAJan 10, 2022AK, AZ, AR +34 more• Shimadzu Medical Systems

SonialVision Safire17 X-Ray (Shimadzu) – Radiation Dose Issue (2022)

High

FDAJan 10, 2022AK, AZ, AR +34 more• Shimadzu Medical Systems

FLUOROspeed X1 X-Ray System (Shimadzu) – Radiation Dose Issue (2022)

High

FDAJan 10, 2022AK, AZ, AR +34 more• Shimadzu Medical Systems

Exeter V40 Cemented Hip 150mm (Howmedica) – Label Mixup (2021)

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

Low

FDADec 30, 2021MI• Howmedica Osteonics Corp.

Exeter V40 Cemented Hip 125mm (Howmedica) – Label Mixup (2021)

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

Low

FDADec 30, 2021MI• Howmedica Osteonics Corp.

Telescoping Dump Cylinder (Crysteel) – Hydraulic Problem (2021)

Crysteel Manufacturing Inc. (Crysteel) is recalling certain Marathon Telescoping Dump Cylinders with a Black Armor finish. The telescopic-style hydraulic cylinder may fail and detach from the hoist cradle.

High

NHTSADec 23, 2021Nationwide• CRYSTEEL

Dall Miles SM Grip (Howmedica) – Packaging De-Bonding Risk (2021)

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Moderate

FDADec 21, 2021PR• Howmedica Osteonics Corp.

V40 Taper Vit Head (Howmedica) – Packaging De-Bonding Risk (2021)

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Moderate

FDADec 21, 2021PR• Howmedica Osteonics Corp.

Flat Panel Detector (Canon Medical) – Image Display Problem (2021)

Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.

Moderate

FDADec 20, 2021Nationwide• Canon Medical System, USA, INC.

Bransist Safire Digital Angiography (Shimadzu) – X-Ray Radiation Exposure (2021)

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Moderate

FDADec 16, 2021CA, FL, GA +12 more• Shimadzu Medical Systems

Shimadzu Trinias Digital Angiography (Shimadzu) – X-Ray Radiation Exposure (2021)

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Moderate

FDADec 16, 2021CA, FL, GA +12 more• Shimadzu Medical Systems

Western Star 4700 (Western Star) – Fuel Injection Tube Risk (2021)

Fire/Burn Risk

Daimler Trucks North America, LLC (DTNA) is recalling certain 2020-2022 Western Star 4700, 2019-2022 Freightliner 114SD, 2021-2022 Western Star 49X, Freightliner Cascadia P4, 2022 Western Star 47X, 2021 Western Star WF110, 2020 Western Star WJ121, and 2019-2021 FCCC XCP Chassis vehicles. The fuel tubes between the fuel rail and the injectors for cylinders four, five, and six may fatigue and crack, which can result in a high pressure fuel leak.

High

NHTSADec 13, 2021Nationwide• WESTERN STAR

STE Wurl Turner (STE) – Chassis Weld Concern (2021)

Stainless Tank and Equipment Co., LLC (STE) is recalling certain 2019-2020 Wurl Turner trailers. The attachment welds on the bottom of the chassis may develop stress fractures, which could result in frame separation.

High

NHTSADec 10, 2021Nationwide• STE

Western Star 4900 (Western Star) – Steering Shaft Bolt (2021)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2021-2022 Western Star 4900 vehicles. The steering shaft pinch bolt may not have been properly tightened, allowing the steering shaft to separate from the steering gear.

High

NHTSADec 8, 2021Nationwide• WESTERN STAR

Zenition 70 (Philips) – Foot Switch Failure (2021)

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Moderate

FDADec 2, 2021AZ, CA, FL +23 more• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands