Siemens Medical Solutions USA, Inc recalls syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows:…
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in…
Read the official notice →- Date
- 2022-07-13
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis…
- Classification
- Class II
- Units
- US Nationwide.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Siemens Medical Solutions recalls
- 2022-07-27
USSiemens Medical Solutions USA, Inc recalls Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or…
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide Distribution AZ FL KY MI OH PR TXOfficial notice →- 2022-07-13
- US
Siemens Medical Solutions USA, Inc recalls Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA,…Official notice → - 2022-07-06
- US
Siemens Medical Solutions USA, Inc recalls Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This…
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide. Foreign distribution to Australia Austria…Official notice → - 2022-06-15
- US
Siemens Medical Solutions USA, Inc recalls Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures…
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts…
- US
Siemens Medical Solutions USA, Inc recalls Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502…
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and…
Other drugs & medical recalls in the United States
- 2022-07-13
- US
Siemens Medical Solutions USA, Inc recalls Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and…
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - US
Rayner Intraocular Lenses Ltd recalls RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer…
The outer package is mislabeled and the package contains a different IOL strength.
FDA · DeviceRayner Intraocular Lenses LtdUS Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO,…Official notice → - US
Chromsystems Instruments & Chemicals GmbH recalls MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
- US
Luminex Corporation recalls VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide and the countries of Kuwait, Austria,…Official notice →