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…
Read the official notice →- Date
- 2022-07-06
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
- Classification
- Class II
- Units
- Domestic distribution nationwide. Foreign distribution to Australia Austria…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-07-13
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 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…
- 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…
- 2022-05-04
US
Siemens Medical Solutions USA, Inc. recalls Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Transducers (component of ultrasound system) may exceed recommended thermal index limits
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-06
US
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or…
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and…
US
Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model #…
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
FDA · DeviceOlympus Corporation of the AmericasNationwide distribution in the US. Foreign distribution worldwide.Official notice →US
ROi CPS LLC recalls regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
A nonsterile component was packaged in a sterile convenience kit.
US
C.R. Bard Inc recalls Sensica Urine Output System
Complaints relating to urine output measurement accuracy.
US
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) recalls ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than…
FDA · DeviceDain Technology, Inc. (Subsidiary of Soundable Health, Inc.)Worldwide distribution - US Nationwide. The software app is distributed via…Official notice →US
Wright Medical Technology, Inc. recalls Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total…
The instrument is incorrectly color coded.
FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →