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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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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
Distribution Pattern US Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813 Class II 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. 6 units Z-1440-2013