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U.S. Department of Health and Human Services

Class 3 Device Recall Sopro Camera Control Unit

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  Class 3 Device Recall Sopro Camera Control Unit see related information
Date Initiated by Firm January 19, 2007
Date Posted May 05, 2007
Recall Status1 Terminated 3 on September 02, 2008
Recall Number Z-0782-2007
Recall Event ID 37819
Product Classification Endoscope camera control unit - Product Code FWF
Product SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
Code Information Serial #s: 420-8283, 420-8275, 420-8285, 420-9006, 420-8271, 420-8277, 420-8289, 420-9015, 420-9000, 420-9001, 420-9002, 420-9004, 420-9005, 420-9007, 420-9008, 420-9009, 420-9010, 420-9012, 420-9014, 420-9016, 420-9017, 420-9018, 420-9019, 420-8282 and 420-9013.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc Endoscopy Division
76 S. Meridian Ave
Oklahoma City OK 73107-6512
Manufacturer Reason
for Recall		 Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
FDA Determined
Cause 2		 Other
Action Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.
Quantity in Commerce 25 units.
Distribution Foreign Distribution Only-No U. S. A. distribution International distribution to: Argentina, Austria, Australia, Belgium, Brazil, China, Columbia, Denmark, Dubai, France, Germany, Greece, Italy, India, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Turkey and United Kingdom.
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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