Recall Z-1946-2024— Newport Corp
Class II · Ongoing
Class II FDA medical device recall by Newport Corp, initiated 2024-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Newport Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-27
- Firm location
- Ivine, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.