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PRODUCT
1) Ellex Motorized Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation. Recall # Z-0577-2010;
2) Motorized Safety Filter, Wild; Model number 6339590. Intended for photocoagulation. Recall # Z-0578-2010
CODE
Solitaire LP4532 photocoagulator
RECALLING FIRM/MANUFACTURER
Ellex Medical Pty LTD, Adelaide, Australia, by letter February 11, 2009. Firm initiated recall is ongoing.
REASON
Potential for two screws important in the design of the safety filter to come loose.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
Internationally |
