Olympus Corporation of the Americas 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-Z-2267-2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L,… Recall
Issued August 9, 2023 · Olympus Corporation of the Americas
In August 2023, Olympus Corporation of the Americas recalled the Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L,…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
What you should do
- 1 Stop using Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas 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
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- August 9, 2023
- Units affected
- Not reported
- Sold at
- Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.
- Recall number
- FDA-Z-2267-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.