Events

Recall of Device Recall Sopro Camera Control Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc Endoscopy Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37819
  • Event Risk Class
    Class 3
  • Event Number
    Z-0782-2007
  • Event Initiated Date
    2007-01-19
  • Event Date Posted
    2007-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51860
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Endoscope camera control unit - Product Code FWF
  • Reason
    Surgical camera control units were not designed and manufactured to pass the iec 60101 testing for electrical fast transients (eft).
  • Action
    Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.

Device

Device Recall Sopro Camera Control Unit
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
  • Manufacturer
    Smith & Nephew, Inc Endoscopy Division

Manufacturer

Smith & Nephew, Inc Endoscopy Division
  • Manufacturer Address
    Smith & Nephew, Inc Endoscopy Division, 76 S. Meridian Ave, Oklahoma City OK 73107-6512
  • Source
    USFDA