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Hitachi Medical Systems America Inc

Hitachi Medical Systems America Inc Recalls

All product recalls associated with Hitachi Medical Systems America Inc.

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Recall Summary

Total Recalls

1000

Past Year

Class I (Serious)

Most Recent

Nov 2025

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 2181–2200 of 2399 recalls

Hitachi Medical Systems America Inc: Hitachi CXR4 Computed Tomography (CT) Scanners, Software ...

Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.

FDAApr 14, 2009Nationwide• Hitachi Medical Systems America Inc

Polymer Technology Systems, Inc.: PTS Panels Cholesterol test strips for self-testing or pr...

The memory chip was coded with incorrect product information.

FDAApr 2, 2009Nationwide• Polymer Technology Systems, Inc.

Apheresis Technologies, Inc.: Owner Manual Modifications for PlasmaPro Plasma Pump Mode...

Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.

1...108 109110111 112...120

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FDAApr 1, 2009Nationwide• Apheresis Technologies, Inc.

Roche Molecular Systems, Inc.: FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Inst...

Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the mutation probe. These rare mutations will lead to an unknown result after performing genotyping.

FDAMar 12, 2009Nationwide• Roche Molecular Systems, Inc.

Polymer Technology Systems, Inc.: PTS Panels CHOL+HDL Panel test strips for professional us...

Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.

FDAFeb 20, 2009Nationwide• Polymer Technology Systems, Inc.

Cyberkinetics Neurotechnology Systems, Inc.: Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expira...

Sterility of product cannot be assured

FDAFeb 4, 2009Nationwide• Cyberkinetics Neurotechnology Systems, Inc.

Xoran Technologies, Inc.: XoranConnect, software version 4.1.0.6, Xoran Technologie...

An incorrect patient name label may appear on the screen displaying the selected patient's scan.

FDAFeb 3, 2009Nationwide• Xoran Technologies, Inc.

Diagnostic Hybrids Inc: Rabbit Kidney Culture, brand name: 'FreshCells'. The pr...

During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).

FDAJan 21, 2009Nationwide• Diagnostic Hybrids Inc

Ryobi Circular Saws (One World) – Safety Defect (2009)

Laceration Risk

This recall involves Ryobi corded circular saws with the following model numbers: CSB123, CSB133L, and CSB142LZ. Circular saws included in this recall have manufacturing date codes between 0836 and 0842 on the data plate near the trigger handle of the saw. Circular saws with a green dot on or near the data plate and on the outside of the package are not subject to this recall.

CPSCJan 13, 2009Nationwide• One World Technologies Inc., of Anderson, S.C.

Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.: V-Probe, Endocare Cryo V Probe model # Cryo 206V. The pr...

Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the Indications and Safety Review included with the Physician Training Materials and to reinforce additional safety information.

FDADec 5, 2008Nationwide• Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.

Micro Therapeutics Inc, dba ev3 Neurovascular: Axium Detachable Coil System Model Number: QC-2-2-3D. Th...

ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.

FDANov 12, 2008Nationwide• Micro Therapeutics Inc, dba ev3 Neurovascular

BD Diagnostics (GeneOhm Sciences, Inc): BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 R...

BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.

FDANov 11, 2008CA, IL, IN +15 more• BD Diagnostics (GeneOhm Sciences, Inc)

Hitachi Medical Systems America Inc: Hitachi CXR4 Computed Tomography Scanner. This product is...

Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).

FDANov 5, 2008Nationwide• Hitachi Medical Systems America Inc

YO-YO Amusement Rides (Chance Rides) – inspection needed (2008)

The recall involves YO-YO amusement rides, consisting of a vertical cylinder with rotating horizontal sweep arms, from which the riding chairs hang.

CPSCOct 8, 2008Nationwide• Chance Rides Manufacturing Inc. (CRM), of Wichita, Kansas

Rockwell Medical Technologies, Inc: SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3....

Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.

FDASep 29, 2008Nationwide• Rockwell Medical Technologies, Inc

Xoran Technologies, Inc.: Xoran MiniCAT System for ENT (server and work station), ...

The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume.

FDASep 17, 2008Nationwide• Xoran Technologies, Inc.

OraSure Technologies, Inc.: Micro Plate EIA Oral Fluid Positive Control which is a co...

Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.

FDASep 8, 2008AZ, CA, CT +16 more• OraSure Technologies, Inc.

OraSure Technologies, Inc.: Micro Plate EIA Oral Fluid Cutoff Calibrator which is a c...

Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.

FDASep 8, 2008AZ, CA, CT +16 more• OraSure Technologies, Inc.

OraSure Technologies, Inc.: Cannabinoids Intercept Micro Plate EIA 100 plate kit

Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.

FDASep 8, 2008IN, NY• OraSure Technologies, Inc.

OraSure Technologies, Inc.: Micro Plate EIA Oral Fluid Negative Control which is a co...

Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.

FDASep 8, 2008AZ, CA, CT +16 more• OraSure Technologies, Inc.