Recall record at a glance
| Official record | Z-2977-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | PACIFIC LASERTECH, LLC |
| Report date | Sep 18, 2024 |
| Recall initiation date | Mar 1, 2024 |
| Quantity | 32 |
| Location | San Marcos, CA, United States |
Official product description
N-LHP-928, HeNe Laser System, 35 mW
Why the product was recalled
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.
Distribution information
US Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: FDA Mandated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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