Siemens AG/Siemens Healthcare GmbH 2024-07-10 Health serious FDA
Health · FDA · Recall #FDA-Z-2241-2024
ARTIS is a family of dedicated angiography systems developed for single and biplane… Recall
Issued July 10, 2024 · Siemens AG/Siemens Healthcare GmbH
In July 2024, Siemens AG/Siemens Healthcare GmbH recalled the ARTIS is a family of dedicated angiography systems developed for single and biplane…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
What you should do
- 1 Stop using ARTIS is a family of dedicated angiography systems developed for single and biplane… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens AG/Siemens Healthcare GmbH to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- Siemens AG/Siemens Healthcare GmbH
- Category
- Health
- Recall date
- July 10, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
- Recall number
- FDA-Z-2241-2024
- Made in
- Germany
- Issuing agency
- FDA
In context
- Siemens AG/Siemens Healthcare GmbH has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.