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U.S. Department of Health and Human Services

Class 2 Device Recall Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro

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  Class 2 Device Recall Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro see related information
Date Initiated by Firm September 12, 2011
Date Posted September 23, 2011
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-3275-2011
Recall Event ID 59908
Product Classification Microscope, surgical - Product Code EPT
Product OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900,
OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4,
OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount.

A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.
Code Information All-OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4,  OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount. 
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information Contact Judith A. Brincombe, M.A.
925-557-4616
Manufacturer Reason
for Recall		 Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems.
FDA Determined
Cause 2		 Pending
Action The firm, Zeiss, sent an "IMPORTANT SAFETY ALERT FOR ZEISS SURGICAL MICROSCOPES" letter dated September 7, 2011, to all affected customers. The letter described the product, problem and action to be taken. The customers were instructed to use surgical drapes compatible with ZEISS surgical microscopes and always follow the instructions for use of the third party navigation system manufacturer for calibration, calibration verification and operation. In addition, the firm supplied customers with a supplement to their Zeiss surgical microscope user documentation and requested that they read the information and keep a copy with their original instructions also the customers were instructed to complete and return the Acknowledgement of Receipt form within 5 business days via fax to 1-866-809-6044 or USPS to Stericycle, Inc., Attn: Event 2480, 2670 Executive Dr. Suite A, Indianapolis, IN 46241. Should you have any questions about this Safety Alert, please contact your Carl Zeiss Customer Care representative at 1-888-871-7120.
Quantity in Commerce 1677 consignees
Distribution Nationwide distribution: USA only.
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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