Xstrahl Limited recalls Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray…
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible…
Read the official notice →- Date
- 2021-11-03
- Country
- United States
- Brand
- Xstrahl
- Product
- Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AZ, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Xstrahl recalls
- 2022-07-27
USXstrahl Limited recalls X80 RADiant Photoelectric Therapy System
There is a potential compatibility issue with the systems and replacement treatment applicators.
- 2021-12-22
- US
Xstrahl Limited recalls Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Base plate may detach from the main body of the treatment applicator.
FDA · DeviceXstrahl LimitedUS and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA,…Official notice →
Other drugs & medical recalls in the United States
- 2021-11-03
- US
Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice → - US
Olympus Corporation of the Americas recalls ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple…
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and…
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution to states of: AL, CA, CT, FL, IL, MD, MI, MN, MO,…Official notice → - US
AB SCIEX recalls Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem…
The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making…
FDA · DeviceAB SCIEXWorldwide distribution - US Nationwide distribution in the states of District…Official notice → - US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls C315-HIS Delivery Catheter
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Distributed internationally to Australia, Brunei Darussalam, China, Germany,…Official notice → - US
W L Gore & Associates, Inc. recalls REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr,…
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
FDA · DeviceW L Gore & Associates, Inc.US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,…Official notice → - US
Smiths Medical ASD Inc. recalls Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Two devices were labeled with the same serial number