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Terminated

SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.

FDA Recall Z-0782-2007 · Posted 2007-05-05

Recalling FirmSmith & Nephew, Inc Endoscopy Division
Recall StatusTerminated
Product CodeFWF
Date Initiated2007-01-19
Date Terminated2008-09-02
Product Quantity25 units.

Reason for Recall

Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)

Firm Action

Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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