Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6…
Read the official notice →- Date
- 2023-09-20
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of IL, WI, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-11-22
USSiemens Medical Solutions USA, Inc recalls Mobilett Mira wireless (VA20) mobile x-ray system(s)
Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual…
- 2023-11-08
- US
Siemens Medical Solutions USA, Inc recalls ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and…
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
- 2023-10-11
- US
Siemens Medical Solutions USA, Inc recalls (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica…
In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential…
- 2023-08-16
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material…
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2023-08-09
- US
Siemens Medical Solutions USA, Inc. recalls The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor…
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the…
FDA · DeviceSiemens Medical Solutions USA, Inc.Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no…Official notice → - 2023-08-02
- US
Siemens Medical Solutions USA, Inc recalls Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care…
Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of FL, GA, KS, MN, NC, NY…Official notice →
Other drugs & medical recalls in the United States
- 2023-09-27
- US
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively…
Lack of Assurance of Sterility
FDA · DrugAMMAN PHARMACEUTICAL INDUSTRIESProduct was distributed to two (2) direct accounts in RI and CO.Official notice → - 2023-09-20
- US
BioFire Diagnostics, LLC recalls FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
FDA · DeviceBioFire Diagnostics, LLCUS:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
- US
Baxter Healthcare Corporation recalls Welch Allyn Connex Spot Monitor
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of CA.Official notice → - US
Keystone Industries recalls Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.:…
The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly…
FDA · DeviceKeystone IndustriesUS Nationwide distribution in the states of IL, PA, FL NV, TX.Official notice → - US
Keystone Industries recalls Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to…
A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
FDA · DeviceKeystone IndustriesWorldwide distribution - US Nationwide and the countries of Canada,…Official notice →