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Terminated

OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.

FDA Recall Z-0105-2012 · Posted 2011-10-24

Recalling FirmCarl Zeiss Meditec, Inc.
Recall StatusTerminated
Product CodeEPT
Date Initiated2011-09-26
Date Terminated2011-11-04
Product Quantity3

Reason for Recall

An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations.

Firm Action

Carl Zeiss Meditec had Field Service Engineers directly contact all affected customers. The Field Service Engineers will replace the defective component. Questions regarding this Field Corrective Action should be directed to the Director of Clinical/Regulatory Affairs at 925-557-4616.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA (nationwide) including the states of FL, GA, and LA .

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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