HeNe Laser System Allows Key Removal While Operating
Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a safety control failure that allows key removal during laser operation. Although no injuries have been reported, the defeat of required safety controls represents a risk-of-harm scenario meeting the criteria for Score 3 (High).
Plain-English summary
Pacific LaserTech is recalling the 25-LHP-828 HeNe Laser System (35 mW). Four units of this laser system were distributed nationwide in the United States.
The recalled systems fail to comply with 21 CFR 1040.10(f)(4), which requires a key-actuated master control on Class IIIb and IV laser products. The regulation specifies that the key shall be removable and the laser shall not be operable when the key is removed. However, the recalled units allow the key to be removed while the laser is switched on.
This defect defeats the safety control that prevents unintended laser operation. The manufacturer has determined that the correction requires replacement of the key switch with one that captures and retains the key when in the on position.
The recalled product
- Product
- 25-LHP-828, HeNe Laser System, 35 mW
- Manufacturer
- PACIFIC LASERTECH, LLC
- Category
- Medical Device — Laser Equipment
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 25-LHP-828
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by PACIFIC LASERTECH, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · PACIFIC LASERTECH, LLC
See all →- HighHeNe Laser System Key Control Can Be Removed While Operating
FDA (Devices) · 2024-09-18
- HighHeNe laser system recalled for removable key safety control defect
FDA (Devices) · 2024-09-18
Same hazard · safety control failure
See all →- HighGE Healthcare MRI system recalled for RF energy safety control failure
FDA (Devices) · 2025-03-05
- HighX-Ray Imaging System May Continue Exposure Beyond Safety Limit
FDA (Devices) · 2025-02-12