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Toshiba American Medical Systems Inc

Toshiba American Medical Systems Inc Recalls

All product recalls associated with Toshiba American Medical Systems Inc.

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Recall Summary

Total Recalls

1000

Past Year

582

Class I (Serious)

Most Recent

Dec 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 9041–9060 of 10937 recalls

Toshiba American Medical Systems Inc: PET-511BTM Multi-plane transesophageal transducer (TEE) u...

Toshiba America Medical Systems Inc is removing the PET-511BTM Multi-plane Transesophageal Transducer from the market after receiving several reports of injury regarding the transducer. Bending or buckling of the flexible portion of the PET-511 BTM multi-plane transesophageal transducer (TEE) may result in injury including perforation.

FDAMay 11, 2009Nationwide• Toshiba American Medical Systems Inc

Acist Medical Systems: ACIST Automated Manifold Kit , REF Model BT2000, SKU # 01...

ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.

FDAMay 11, 2009AL, AZ, AR +39 more• Acist Medical Systems

Varian Medical Systems Oncology Systems: Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, ...

1...451 452453454 455...547

Page 453 of 547Next

Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.

FDAMay 8, 2009Nationwide• Varian Medical Systems Oncology Systems

GE Medical Systems, LLC: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 0...

GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) an

FDAMay 8, 2009AL, AK, AZ +34 more• GE Medical Systems, LLC

Off-Road Motorcycles (KTM) – Front Fork Failure (2009)

This recall involves model year 2009 KTM off-road motorcycles. The model name and KTM™ logo are located on the right and left shrouds. The following models are included in this recall:Model Name Description 125SX Orange / Black 150SX Orange / Black 250XC-W Orange / Black 300XC-W Orange / Black

CPSCMay 7, 2009Nationwide• KTM North America Inc., of Amherst, Ohio

Torcofix/Torcoflex Torque Wrenches (Richard Abraham Herder) – Injury Risk (2009)

The wrenches were sold under three styles names: Richard Abraham Herder KG "Gedore/Rahsol" label, the Mountz "Titan" label, and the Mountz "Erico" label. Only wrenches with the serial numbers within the following ranges are included in the recall: From serial no. To serial no. 1268368 1341104 A003977 A039760 B000493 B032301 C000001 C017795 E000001 E020205 F000001 F013249 H000001 H000128 2174340 2230753 Recalled wrenches include the following product/brand names and model numbers: Product/Brand Name Model Nos. GEDORE/RAHSOL TORCOFIX K with Ratchet 4550-10; 4550-20; 4550-30; 4550-40 GEDORE/RAHSOL TORCOFLEX K with Ratchet 3550-07; 3550-10; 3550-20; 3550-30; 3550-2006 GEDORE/RAHSOL TORCOFIX Z with Spigot 4410-01; 4420-01; 4430-01; 4440-01 GEDORE/RAHSOL TORCOFIX SE with rectangle holder 4100-01; 4200-02; 4201-01; 4300-01; 4301-01 GEDORE/RAHSOL TORCOFIX K US with Ratchet 6550-15; 6551-07; 6551-10; 6551-30; 6551-60 MOUNTZ TITAN with Ratchet 280012; 280013; 280014 MOUNTZ TITAN with Spigot 280022; 280023; 280024 MOUNTZ ERICO ELT110D with Ratchet ELT110D The serial number is printed on the side of every torque wrench and the model number is printed on the label on the front and the back of the steel tube.

CPSCMay 6, 2009Nationwide• Richard Abraham Herder KG, of Solingen, Germany

Erwin and Poseidon Beanie Hats (Ambler Mountain Works) – Choking Hazard (2009)

Choking Hazard

The Erwin Beanie is primarily green and white yarn knitted to configure a frog with white eyeballs and a red smile. The Poseidon Beanie comes in several colors of yarn and has hand sewn turtles, whales and octopus attached to the beanie. The beanies have the firm's logos "Ambler" or "A" printed on a fabric tag.

CPSCMay 5, 2009Nationwide• Ambler Mountain Works, of Canmore, Alberta, Canada

GE Medical Systems, LLC: GE Healthcare, CT Perfusion 4 on Advantage Workstation, C...

GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater th

FDAMay 4, 2009AZ, CA, CT +17 more• GE Medical Systems, LLC

GE Medical Systems, LLC: HiSpeed X/i Computed Tomography operator consoles with th...

It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.

FDAMay 1, 2009AL, CA, CT +9 more• GE Medical Systems, LLC

Kamiya Biomedical Company, LLC: "K-ASSAY CRP (3) Calibrator E". This product is an IVD ...

The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.

FDAMay 1, 2009Nationwide• Kamiya Biomedical Company, LLC

Philips Medical Systems North America Co. Phillips: The product's marketing brochure states: "1.5T coils and ...

Fire/Burn Risk

Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.

FDAMay 1, 2009Nationwide• Philips Medical Systems North America Co. Phillips

Becton Dickinson & Company: BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Cata...

Potential for compromised sterility: Insufficient packaging seals.

FDAApr 30, 2009Nationwide• Becton Dickinson & Company

Disetronic Medical Systems, Inc.: Roche ACCU-CHEK Spirit insulin pump. Part numbers 454049...

The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.

FDAApr 30, 2009Nationwide• Disetronic Medical Systems, Inc.

Philips Medical Systems (Cleveland) Inc: Dental Application on the Extended Brilliance Workspace v...

Philips Healthcare has decided to recall the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.

FDAApr 27, 2009AL, AZ, AR +22 more• Philips Medical Systems (Cleveland) Inc

OPTI Medical Systems, Inc: OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), O...

Outer box labeling shows an incorrect storage temperature range.

FDAApr 20, 2009Nationwide• OPTI Medical Systems, Inc

GE Medical Systems, LLC: GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system ...

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra

FDAApr 16, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Signa Ovation 0.35 T MR System. The Signa Ovation Sys...

GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation, may hit

FDAApr 16, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC

GE Medical Systems, LLC: Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging Sys...

FDAApr 16, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Signa OpenSpeed 0.7T MR System. The 0.7T Signa OpenSp...

FDAApr 16, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC

Cardiovascular Systems, Inc.: Diamondback 360 Orbital Atherectomy Device, 1.50 LT Class...

CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s

FDAApr 16, 2009Nationwide• Cardiovascular Systems, Inc.