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Picasso Plus Strippable Fiber Cable
CAO GROUP, INC. · Model SF400-PLUS · UDI-DI 00872320004279
GEX
Prescription
10
510(k) clearances
43,846
Adverse events (107 deaths)
200
Recalls
485
Facilities
Description
Strippable optical fiber cable for use with the Picasso Lite Plus and Picasso Plus diode lasers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-05 | IPG Medical Corporation | Software anomaly that causes a false display of error code 5018. |
| 2026-02-27 | Olympus Corporation of the Americas | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperabl |
| 2026-02-27 | Olympus Corporation of the Americas | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperabl |
| 2026-01-27 | Lutronic Corporation | Reports of devices sparking/popping and potentially burning patients. |
| 2025-12-15 | LEASEIR TECHNOLOGIES SLU | The console label for affected devices is missing the "DANGER" symbol. |
| 2025-07-22 | LUMENIS, LTD. | The potential for unsterilized product within finished product labeled as sterile. |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.