medical Class II Updated 2018-08-01

Leica Microsystems, Inc. recalls Leica Microsystems products labeled as the following: Leica

Recalled Product

Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.


Hazard / Issue

Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: A. Article Number 10448419 (Serial Numbers 160714001, 10814001, 200814001, 200814002, 90914001, 021014001, 21214001, 31214001, 81214001, 190115001, 190115002); B Article Number 10448420 (Serial Numbers 180514001, 180514002, 190514001, 190514002, 190514003, 190514004, 200514001, 200514002, 200514003, 200514004, 210514001, 210514002, 210514003, 210514004, 220514001, 220514002, 220514003, 260514001, 260514002, 270514001, 270514002, 270514003, 270514004, 270514005, 280514001, 280514002, 280514003, 290514001, 300514001, 300514002, 300514003, 20614001, 40614001, 50614001, 50614002, 50614003, 60614001, 90614001, 90614002, 100614001, 100614002, 100614003, 120614001, 120614002, 120614003, 130614001, 130614002, 130614003, 130614004, 90514002, 160614001, 160614002, 160614003, 160614004, 170614001, 190614001, 200614001, 200614002, 200614003, 230614001, 230614002, 230614003, 240614001, 250614001, 250614002, 250614003, 250614004, 250614005, 270614001, 300614001, 300614002, 300614003, 10714001, 10714002, 10714003, 10714004, 20714001, 20714002, 20714003, 30714001, 30714002, 40714001, 40714002, 40714003, 70714001, 70714002, 70714003, 80714001, 80714002, 80714003, 90714001, 100714001, 110714001, 140714001, 160714001, 160714002, 170714001, 170714002, 180714001, 180714002, 180714003, 210714001, 210714002, 210714003, 220714001, 220714002, 220714003, 220714004, 230714001, 250714001, 250714002, 250714003, 250714004, 250714005, 250714006, 290714001, 290714002, 290714003, 290714004, 300714001, 300714002, 300714003, 300714004, 310714001, 310714002, 310714003, 310714004, 10814001, 10814002, 040814001, 040814002, 040814003, 040814004, 050814001, 050814002, 050814003, 050814004, 060814001, 060814002, 070814001, 070814002, 070814003, 070814004, 080814001, 080814002, 120814001, 120814002, 130814001, 130814002, 130814003, 130814004, 140814001, 140814002, 140814003, 140814004, 150814001, 150814002, 150814003, 160814001, 160814002, 160814003, 180814001, 180814002, 180814003, 190814001, 190814002, 190814003, 190814004, 190814005, 190814006, 200814001, 200814002, 210814001, 210814002, 210814003, 210814004, 220814001, 220814002, 220814003, 250814001, 250814002, 270814001, 270814002, 270814003, 270814004, 270814005, 270814006, 280814001, 280814002, 280814003, 280814004, 290814001, 290814002, 10914001, 10914002, 10914003, 10914004, 20914001, 20914002, 30914001, 30914002, 30914003, 80714002, 70814003, 40914001, 40914002, 50914001, 50914002, 80914001, 80914002, 80914003, 80914004, 80914005, 90914001, 90914002, 90914003, 100914001, 100914002, 100914003, 100914004, 110914001, 110914002, 110914003, 120914001, 120914002, 120914003, 120914004, 120914005, 130914001, 130914002, 130914003, 150914001, 160914001, 160914002, 160914003, 160914004, 160914005, 170914001, 170914002, 170914003, 170914004, 170914005, 180914001, 180914002, 180914003, 180914004, 180914005, 190914001, 190914002, 190914003, 200914001, 200914002, 200914003, 200914004, 200914005, 220914001, 220914002, 220914003, 220914004, 230914001, 230914002, 90614001, 90614002, 240914001, 240914002, 240914003, 250914001, 250914002, 100614002, 100614003, 260914001, 260914002, 260914003, 260914004, 290914001, 290914002, 290914003, 300914001, 300914002, 300914003, 021014001, 021014002, 031014001, 031014002, 031014003, 031014004, 41014001, 41014002, 41014003, 41014004, 41014005, 41014006, 41014007, 61014001, 61014002, 71014001, 71014002, 71014003, 71014004, 81014001, 81014002, 81014003, 81014004, 81014005, 91014001, 91014002, 101014001, 101014002, 101014003, 101014004, 121014001, 121014002, 121014003, 121014004, 121014005, 121014006, 131014001, 141014001, 141014002, 141014003, 141014004, 151014001, 151014002, 151014003, 151014004, 161014001, 161014002, 161014003, 171014001, 171014002, 171014003, 171014004, 181014001, 181014002, 181014003, 181014004, 191014001, 191014002, 191014003, 191014004, 201014001, 201014002, 201014003, 211014001, 211014002, 211014003, 211014004, 231014001, 231014002, 231014003, 241014001, 241014002, 241014003, 241014004, 241014005, 281014001, 281014002, 281014003, 281014004, 281014005, 291014001, 291014002, 291014003, 291014004, 291014005, 291014006, 301014001, 301014002, 311014001, 311014002, 311014003, 311014004, 11114001, 11114002, 11114003, 11114004, 11114005, 31114001, 31114002, 31114003, 31114004, 31114005, 41114001, 41114002, 41114003, 51114001, 51114002, 51114003, 51114004, 81114001, 81114002, 81114003, 81114004, 101114001, 101114002, 101114003, 111114001, 111114002, 121114001, 121114002, 121114003, 121114004, 131114001, 131114002, 141114001, 141114002, 141114003, 161114001, 161114002, 161114003, 161114004, 161114005, 161114006, 171114001, 171114002, 171114003, 171114004, 181114001, 181114002, 181114003, 191114001, 191114002, 191114003, 201114001, 201114002, 201114003, 201114004, 201114005, 211114001, 211114002, 211114003, 211114004, 241114001, 241114002, 241114003, 241114004, 251114001, 251114002, 251114003, 251114004, 261114001, 261114002, 261114003, 261114004, 271114001, 271114002, 281114001, 281114002, 11214001, 11214002, 21214001, 31214001, 31214002, 31214003, 41214001, 41214002, 41214003, 51214001, 51214002, 71214001, 71214002, 81214001, 81214002, 81214003, 91214001, 91214002, 91214003, 91214004, 101214001, 101214002, 101214003, 111214001, 111214002, 111214003, 121214001, 121214002, 121214003, 121214004, 151214001, 151214002, 151214003, 151214004, 151214005, 151214006, 151214007, 151214008, 161214001, 161214002, 171214001, 171214002, 171214003, 181214001, 181214002, 181214003, 181214004, 191214001, 191214002, 191214003, 191214004, 191214005, 191214006, 211214001, 221214001, 221214002, 241214001, 241214002, 241214003, 261214001, 261214002, 261214003, 261214004, 271214001, 271214002, 271214003, 281214001, 281214002, 281214003, 20115001, 20115002, 20115003, 20115004, 50115001, 50115002, 60115001, 60115002, 60115003, 60115004, 60115005, 60115006, 70115001, 70115002, 80115001, 80115002, 90115001, 90115002, 90115003, 90115004, 110115001, 110115002, 120115002, 120115003, 120115004, 130115001, 130115002, 130115003, 130115004, 140115001, 140115002, 140115003, 140115004, 150115001, 150115002, 160115001, 160115002, 190115001, 190115002, 200115001, 200115002, 200115003, 200115004, 210115002, 210115004, 130215004, 110515005, 120115004, 130115003, 50915001); C. Article Number 10448485 (Serial Numbers 180514001, 180514002, 230514001, 230514002, 230514003, 230514004, 260514001, 260514002, 280514001, 290514001, 20614001, 20614002, 20614003, 30614001, 30614002, 40614001, 40614002, 60614001, 60614002, 90614001, 90614002, 110614001, 110614002, 170614001, 170614002, 170614003, 170614004, 170614005, 180614001, 190614001, 190614002, 190614003, 190614004, 190614005, 200614001, 230614001, 300614001, 20714001, 30714001, 30714002, 40714001, 80714001, 90714001, 90714002, 100714001, 100714002, 110714001, 110714002, 140714001, 140714001, 170714001, 180714001, 210714001, 080814001, 080814002, 120814001, 120814002, 150814001, 220814001, 260814001, 260814002, 260814003, 260814004, 290814001, 290814002, 20914001, 20914002, 50914001, 50914002, 110914001, 130914001, 150914001, 150914002, 230914001, 240914001, 250914001, 250914002, 290914001, 300914001, 011014001, 011014002, 011014003, 011014004, 021014001, 41014001, 61014001, 91014001, 91014002, 101014001, 121014001, 151014001, 211014001, 231014001, 241014001, 241014002, 301014001, 301014002, 301014003, 311014001, 11114001, 11114002, 11114003, 41114001, 81114001, 101114001, 111114001, 111114002, 191114001, 211114001, 271114001, 271114002, 281114001, 11214001, 21214001, 21214002, 51214001, 71214001, 71214002, 71214003, 101214001, 111214001, 161214001, 161214002, 171214001, 191214001, 191214002, 221214001, 221214002, 231214001, 231214002, 231214003, 241214001, 251214001, 251214002, 251214003, 70115001, 80115001, 80115002, 150115001, 150115002, 160115001, 160115002); D. Article Number 10448486 (Serial Numbers 110614001, 110614002, 120614001, 310114001, 060814001, 060814002, 160814001, 61014001, 121014001, 281014001, 131114001, 131114002, 181114001, 231214001)
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