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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-0781-2007
Recall Event ID 37819
Product Classification Endoscope camera control unit - Product Code FWF
Product SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
Code Information Serial #s: BE, 420-8161, 420-8013, 420-8026, 420-8056, 420-8041, 420-8134, 420-8137, 420-8059, 420-8135, 420-8010, 420-8014, 420-8132, 420-8018, 420-8020, 420-8035, 420-8045, 420-8114, 420-8115, 420-8136, 420-8140, 420-8143, 420-8146, 420-8149, 420-8155, 420-8113, 420-8142, 420-8151, 420-8154, 420-8058, 420-8050, 420-8033, 420-8138, 420-8038, 420-8054, 420-8036, 420-8037, 420-8043, 420-8133, 420-8025, 420-8015, 420-8019, 420-8028, 420-8030, 420-8031, 420-8032, 420-8042, 420-8049, 420-8057, 420-8039, 420-8119, 420-8120, 420-8040, 420-8118, 420-8145, 420-8152, 420-8046, 420-8011, 420-8055, 420-8141, 420-8021, 420-8112, 420-8024, 420-8048, 420-8144, 420-8016, 420-8017, 420-8022, 420-8023, 420-8047, 420-8052, 420-8044, 420-8034, 420-8053, 420-8029, 420-8051, 420-8058.
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 77 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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