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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
Recall Number Z-1440-2013
Classification Class II
Code Info Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813
Product Distributed Qty 6 units
Reason For Recall Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.

Event Detail

Event Id 65109
Product Type Devices
Status Ongoing
Recalling Firm Carl Zeiss Meditec, Inc.
City Dublin
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution.