Elekta Instrument AB 2023-04-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1309-2023
Instructions for Use for the following Leksell Stereotactic System and Leksell… Recall
Issued April 5, 2023 · Elekta Instrument AB
In April 2023, Elekta Instrument AB recalled the Instructions for Use for the following Leksell Stereotactic System and Leksell…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The incorrect IFU was distributed with the devices.
What you should do
- 1 Stop using Instructions for Use for the following Leksell Stereotactic System and Leksell… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Elekta Instrument AB to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Elekta Instrument AB
- Category
- Health
- Recall date
- April 5, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC,
- Recall number
- FDA-Z-1309-2023
- Made in
- Sweden
- Issuing agency
- FDA
In context
- Elekta Instrument AB has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.