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U.S. Department of Health and Human Services

Class 2 Device Recall OPMI Pentero C

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  Class 2 Device Recall OPMI Pentero C see related information
Date Initiated by Firm April 18, 2013
Date Posted May 31, 2013
Recall Status1 Terminated 3 on June 26, 2013
Recall Number Z-1440-2013
Recall Event ID 65109
Product Classification Microscope, surgical - Product Code EPT
Product 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.
Code Information Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information Contact Judith A. Brimacombe, M.A.
925-557-4616
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Carl Zeiss Meditec, Inc sent a Customer Notification letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that firm's sales representative will be scheduling an on-site visit, informing them of the affected product and providing instructions on the recall. For question call 925-580-5371.
Quantity in Commerce 6 units
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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