FDAClass IIAugust 1, 2012

Leica M525 F50 Surgical Microscope recall

Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product…

Why was Leica M525 F50 Surgical Microscope recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product…
Recalling firm
Leica Microsystems, Inc.
Quantity
39 Units - USA , 4 Units - Canada
Distribution
Worldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada.
Recall date
August 1, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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