RecallRadar

FDA Device recall Z-2053-2012

Leica M525 F50 Surgical Microscope

On 2012-08-01 the FDA classified a Class II recall of Leica M525 F50 Surgical Microscope by Leica Microsystems, citing leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2053-2012
ClassificationClass II
Statusterminated
Initiated2012-06-04
Published2012-08-01
Last updated2026-09-13 11:53 UTC
CompanyLeica Microsystems
DistributionUS

Product

Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

Reason

Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.

Identifiers

code_info
Serial numbers serial numbers 110311001, 120312001, 20412001, 260112001, 300911001, 40811001, 80411001, 90312001, 10311…Serial numbers serial numbers 110311001, 120312001, 20412001, 260112001, 300911001, 40811001, 80411001, 90312001, 10311002, 90611001, 260711001, 20911001, 200911001, 210911001, 111011001, 141011001, 241011001, 121211001, 141211001, 151211001, 191211001, 30112001, 50112001, 140212001, 60312001, 220312001, 300312001, 30412001, 50411001, 10411001, 130411001, 210411001, 170511001, 300511001, 90811001, 200312001, 50412001, 110112002, 280611001, 241011002, 20312001, 101011001 and 270911001

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2053-2012%22

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