Scan slit lamp delivery unit (SL-1800)
NIDEK CO.,LTD. · Model 17482-0000 · UDI-DI 04987669100196
Description
This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800/SL-1600. A scan slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the MC-500 main body. A scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the NIDEK SL-1800/SL-1600 slit lamp for lasers to comprise a scan slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. A photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | Beaver-Visitec International, Inc. | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. Th |
| 2023-03-16 | Ellex Medical Pty Ltd. | When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output |
| 2021-04-14 | Dutch Ophthalmic USA, Inc. | Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01 |
| 2016-07-15 | Topcon Medical Laser Systems, Inc | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) fun |
| 2016-02-01 | Laserex Systems Inc. | The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented. |
| 2014-12-18 | Ziemer Usa Inc | The devices were not shipped with the Starter Kits. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-08-15 | Lumenis, Inc. | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different |
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