Reported Jun 12, 2024 · Ongoing

Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as…

Newport Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Newport Corp · Unknown Street · Ivine, CA · 92606

Is this the product you have?

  • Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
Lot codes and dates
  • P/N N-LHP-928 Set S/N (laser head +
  • power supply)
    • 6905AE
    • 6907AE
    • 9023AE
    • 3148AF
    • 6899AE 6909AE
    • 9025AE
    • 5695AF
    • 5696AF
    • 5691AF
    • 5692AF
    • 5693AF
    • 5694AF (9
  • of them in Irvine warehouse) P/NN6-LPL-944-080
  • Power supply S/N
    • 23060081
    • 23060079
Amount recalled
19

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

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