December 25, 2019
Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 12/25/2019 Class II PRODUCT VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of...
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Company: GE Healthcare, LLC Date of Enforcement Report: 12/25/2019 Class II PRODUCT Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571 Recall Number: Z-0114-2020 REASON Certain Aespire and Aestiva Anesthesia Systems were...
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