Newport Corp 2024-06-12 Health serious FDA
Health · FDA · Recall #FDA-Z-1946-2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080… Recall
Issued June 12, 2024 · Newport Corp
In June 2024, Newport Corp recalled the Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern.
What you should do
- 1 Stop using Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Newport Corp 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
- Newport Corp
- Category
- Health
- Recall date
- June 12, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide
- Recall number
- FDA-Z-1946-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Newport Corp 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.