25-LHP-828, HeNe Laser System, 35 mW

FDA device recall Z-2975-2024 · posted 2024-09-10 · Open, Classified

Recall details

Recalling firm

PACIFIC LASERTECH, LLC

Reason for recall

These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, 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. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.

Action taken

The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.

Root cause

Radiation Control for Health and Safety Act

Status

Open, Classified

Product code

RDW

Quantity affected

4

Distribution

US Nationwide Distribution

Date initiated

2024-03-01

Date posted

2024-09-10

Location

San Marcos, CA