Model LightLas 532 Opthalmic Photocoagulator Laser
FDA device recall Z-0228-04 · posted 2003-12-17 · Terminated
Recall details
- Recalling firm
- LightMed USA Inc
- Reason for recall
- Firm needed to include calibration procedures in user guide.
- Action taken
- Firm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 2
- Distribution
- CA, GA
- Date initiated
- 2003-11-11
- Date posted
- 2003-12-17
- Date terminated
- 2003-12-16
- Location
- San Clemente, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGHTLAS 532 PHOTOCOAGULATOR (K010372) | Lightmed Corp. | 2001-08-22 |
| LPULSA SYL-9000 OPHTHALMIC YAG LASER (K990075) | Light-Med(Usa), Inc. | 1999-03-30 |