Devices

Device Recall Ellex Solitarie Opthalmic Laser System

Model / Serial
Solitaire-DGS P/N 303896 (serial # /system #): 31577 /4A2149, 32263 /4A2150, 32256 /4A2152, 32224 /4A2162, 32264 /4A2165, 32627 /4A2174D Solitarie-SGS P/N 3038960 serial # /system #): 31313 /4A2129, 32223 /4A2148, 32728 /4A2160, 32733 /4A2175S
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.
Product Description
Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
Manufacturer
Ellex USA
1 Event
- Recall of Device Recall Ellex Solitarie Opthalmic Laser System

Manufacturer

Ellex USA

Manufacturer Address
Ellex USA, 7138 Shady Oak Road, Eden Prairie MN 55344
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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