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Hitachi America, Ltd., Particle Therapy Division

Hitachi America, Ltd., Particle Therapy Division Recalls

All product recalls associated with Hitachi America, Ltd., Particle Therapy Division.

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Recall Summary

Total Recalls

1000

Past Year

593

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 941–960 of 10391 recalls

PROBEAT-FR (Hitachi) – Image Matching Software Error (2024)

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

FDAMay 27, 2024Nationwide• Hitachi America, Ltd., Particle Therapy Division

Cue COVID-19 Test Cartridge (CUE HEALTH) – Unauthorized Distribution (2024)

Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.

FDAMay 24, 2024Nationwide• CUE HEALTH INC

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

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FDAMay 22, 2024Nationwide• Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

Avalon Ultrasound Transducer (Philips) – Fetal Measurement Error (2024)

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

FDAMay 22, 2024Nationwide• Philips North America Llc

OSSOS-SANS Tablets (MexHealth) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,

Class IIModerate

FDAMay 22, 2024Nationwide• MexHealth LLC

RAPIDPoint 500e Blood Gas System (Siemens) – Sample Source Identification (2024)

Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.

FDAMay 17, 2024Nationwide• Siemens Healthcare Diagnostics Inc

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Philips Allura Xper FD10 System (PHILIPS) – Brake Engagement Issue (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Electric Ranges (Frigidaire/Kenmore) – Fire Hazard (2024)

Fire/Burn Risk

This recall reannouncement involves Frigidaire, Frigidaire Gallery, Frigidaire Professional, and Kenmore Elite smooth-top electric ranges. The smooth-top electric ranges have rear panel rotary knobs and digital displays. They were sold in the following colors: white, bisque, black and stainless steel. The brand name, model, and serial number for each unit are located on the frame of the drawer at the bottom of the unit when the drawer is opened. The following models and serial numbers are included in the recall: Rose Pink, Light Pink, Pure White, Falcon Gray and Green Mist, with Light Blue, Navy, Peacock Blue, Gray Frigidaire Models Model Numbers FEFBZ90GC* FEFLMC55GC* FEFLZ87GC* GLEF396AB* GLEF396AQ* GLEF396AS* GLEF396CQ* GLEF396CS* GLEFM397DB* GLEFM397DQ* GLEFM397DS* GLEFM97FPB* GLEFM97FPW* GLEFM97GPB* GLEFM97GPW* LEEFM389FE* PLEF398AC* PLEF398CC* PLEF398DC* PLEFM399DC* PLEFMZ99EC* PLEFMZ99GC* PLEFZ398EC* PLEFZ398GC* Frigidaire Serial Numbers Serial Number Range VF122xxxxx - VF334xxxxx Kenmore Elite Models Model Numbers 790.990121* 790.990131* 790.990141* 790.990191* Kenmore Elite Serial Numbers Serial Number Range VF122xxxxx - VF334xxxxx

CPSCMay 16, 2024Nationwide• Electrolux Home Products Inc., of Charlotte, North Carolina

Pregabalin Capsules (Rising Pharma) – Foreign Tablet Found (2024)

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

Class IIILow

FDAMay 16, 2024Nationwide• Rising Pharma Holding, Inc.

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Ventilator HAMILTON-C6 (Hamilton Medical) – Sensor Fail Mode (2024)

Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

FDAMay 15, 2024Nationwide• Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland

Sight OLO CBC Test Kit (Sight Diagnostics) – Platelet Count Bias (2024)

One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.

FDAMay 13, 2024Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

HistoCore Arcadia H (Leica) – Smoke and Fire Hazard (2024)

Fire/Burn Risk

An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

FDAMay 10, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

Price Chopper Cottage Cheese (HP Hood) – Undeclared Sugar (2024)

Undeclared Allergen

Contains undeclared sugar

Class IIModerate

FDAMay 10, 2024NY• HP Hood (LAFARGEVILLE)

Lundberg Wild Blend Rice (Wehah Farms) – Potential Rodent Object (2024)

Product may contain foreign object that appears to be of rodent origin.

Class IIModerate

FDAMay 10, 2024AZ, CA, FL +4 more• Wehah Farms

Mt. Capra Goat Milk Formula Kit (Mt. Capra) – FDA Notification Issue (2024)

The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket notification required for an infant formula for review.

Class IHigh

FDAMay 10, 2024Nationwide• Healthwest Minerals, Inc. dba Mt. Capra Products

Philips Tempus LS Defibrillator (Remote Diagnostic) – ECG Interference (2024)

Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

FDAMay 9, 2024Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Hoffman LRF Wire Tensioner (Stryker) – Adjustment Ring Issue (2024)

The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

FDAMay 9, 2024Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Centrella Smart+ Bed (Baxter) – Mattress Delamination Risk (2024)

There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.

FDAMay 8, 2024Nationwide• Baxter Healthcare Corporation