FDA Device recall Z-2555-2018
Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 1044…
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 1044… by Leica Microsystems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2555-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-04 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Leica Microsystems |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | A. Article Number 10448419 (Serial Numbers 160714001, 10814001, 200814001, 200814002, 90914001, 021014001, 21214001, 31…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2555-2018%22
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