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.
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. Distribution: US Nationwide Quantity: 19 Lot/code info: 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/N: N6-LPL-944-080 Power supply S/N: 23060081, 23060079
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.