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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80229

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 04, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Leica Microsystems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2555-2018
Recall number
Z-2555-2018
Initiated
June 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
Leica Microsystems, Inc.
Quantity
8,564 Total Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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)

Distribution pattern

Worldwide Distribution US Nationwide in the states of : CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX. International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE, CHINA, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONGKONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, MALAYSIA, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN,THAILAND, TURKEY, UK