SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew,
FDA device recall Z-0781-2007 · posted 2007-05-05 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division
- Reason for recall
- Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
- Action taken
- Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.
- Root cause
- Other
- Status
- Terminated
- Product code
- FWF
- Quantity affected
- 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
- Date initiated
- 2007-01-19
- Date posted
- 2007-05-05
- Date terminated
- 2008-09-02
- Location
- Oklahoma City, OK
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