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Leica Microsystems, Inc. FDA Recalls
9 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope systemClass IINov 21, 2022There is a potential issue resulting in the Power Supply pot |
| Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope systemClass IINov 21, 2022There is a potential issue resulting in the Power Supply pot |
| Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope systemClass IINov 21, 2022There is a potential issue resulting in the Power Supply pot |
| Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063Class IIAug 26, 2022During internal testing, Leica Microsystems has become aware |
| Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950Class IIAug 26, 2022During internal testing, Leica Microsystems has become aware |
| Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737Class IIAug 26, 2022During internal testing, Leica Microsystems has become aware |
| Leica Surgical Operating Microscopes, Arveo, Part Number 10448999Class IIAug 26, 2022During internal testing, Leica Microsystems has become aware |
| Leica Microsystems M220 F12 Microscope SystemsClass IINov 3, 2021In May 2021, Leica Microsystems received one (1) complaint p |
| BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375Class IIJul 30, 2021Product may not perform as specified in IFU. |