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Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc. Recalls

All product recalls associated with Siemens Medical Solutions USA, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

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 18641–18660 of 21320 recalls

Siemens Medical Solutions USA, Inc.: Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems ...

Image error: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

FDAJul 10, 2007Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Siemens, ACUSON Antares, Ultrasound System (Standard and ...

Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

FDAJul 10, 2007Nationwide• Siemens Medical Solutions USA, Inc.

GE OEC Medical Systems, Inc: GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE ...

1...931 932933934 935...1066

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The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

FDAJul 6, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray syste...

The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

FDAJul 6, 2007Nationwide• GE OEC Medical Systems, Inc

Focus Diagnostics Inc: HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended...

A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.

FDAJul 6, 2007CA, CT, IL +2 more• Focus Diagnostics Inc

Pacific Bioscience Lab, Inc.: Clarisonic Skin Care System - A hand held cleansing devic...

Fire/Burn Risk

Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.

FDAJul 3, 2007IN• Pacific Bioscience Lab, Inc.

Biomedicare, Inc.: Biomedicare Implantium Fixtures, Model numbers : FX3408, ...

Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date.

FDAJun 29, 2007AZ, CA, IL +3 more• Biomedicare, Inc.

Boston Scientific Corp: Polaris Dx Diagnostic Catheter, for cardiac electrophysio...

Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).

FDAJun 26, 2007FL, IN, TN• Boston Scientific Corp

Ventana Medical Systems Inc: Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2...

Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.

FDAJun 26, 2007Nationwide• Ventana Medical Systems Inc

Varian Medical Systems Inc: Ximatron Digital Imaging (Ximavision), V 7.5.51 with Serv...

Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.

FDAJun 25, 2007MO, NY• Varian Medical Systems Inc

Medtronic Neuromodulation: Medtronic InterStim INS (Model 3023) with N'Vision Inter ...

Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

FDAJun 25, 2007Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic InterStim II INS Model 3058 with N'Vision Inter...

A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .

FDAJun 25, 2007Nationwide• Medtronic Neuromodulation

Sybaritic, Inc: DERMALIFE Spa Feng Shui 2G. Part #E30007-100 is: Spa-F...

A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan failure which resulted in the overheating and failure of the IR emitter and surrounding assembly.

FDAJun 22, 2007CA, IA, MN +5 more• Sybaritic, Inc

Sybaritic, Inc: DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/...

FDAJun 22, 2007CA, IA, MN +5 more• Sybaritic, Inc

Sybaritic, Inc: DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2...

FDAJun 22, 2007CA, IA, MN +5 more• Sybaritic, Inc

Radiometer America Inc: Pump waste tube for blood gas analysis kit. One yellowish...

Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.

FDAJun 22, 2007Nationwide• Radiometer America Inc

Sybaritic, Inc: DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oc...

FDAJun 22, 2007CA, IA, MN +5 more• Sybaritic, Inc

Becton Dickinson & Company: ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gaug...

Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

FDAJun 21, 2007Nationwide• Becton Dickinson & Company

Possis Medical, Inc: Possis AngioJet XVG Thrombectomy Sets, Model/Order # 1050...

Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries.

FDAJun 19, 2007AZ, AR, CA +25 more• Possis Medical, Inc

Synovis Surgical Inovation Div. of: Allez Medical Applications, Inc. 4Closure Surgical Fascia...

There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.

FDAJun 19, 2007Nationwide• Synovis Surgical Inovation Div. of