Events

Recall of Endoscope light source.

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
    37849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0840-2007
  • Event Initiated Date
    2007-04-09
  • Event Date Posted
    2007-06-07
  • 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=51944
  • 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 light source - Product Code FFS
  • Reason
    Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. when the unit's power supply draws more that 1a, the fuse will fail causing the light to cease operating. the problem can occur anytime: from the initial turning on (powering up), to anytime during use.
  • Action
    Notification sent 04/09/07 via FedEx to distribution centers, sales reps and user facilities. Users asked to send light source to Smith & Nephew GMBH Service Center in Germany for repair (contact Ute Dieling at +49 (0) 7462-208-313).

Device

Endoscope light source.
  • Model / Serial
    Serial #s: 420L-1263, 420L-1264, 420L-1265, 420L-1266, 420L-1267, 420L-1268, 420L-1269, 420L-1270, 420L-1271, 420L-1272, 420L-1273, 420L-1275, 420L-1277, 420L-1280, 420L-1281, 420L-1282, 420L-1283, 420L-1284, 420L-1285, 420L-1286, 420L-1287, 420L-1288, 420L-1292, 420L-1293, 420L-1294, 420L-1295, 420L-1296, 420L-1298, 420L-1300, 420L-1301, 420L-1303, 420L-1304, 420L-1305, 420L-1306, 420L-1307, 420L-1308, 420L-1309, 420L-1310, 420L-1311, 420L-1312, 420L-1313, 420L-1314, 420L-1315, 420L-1316, 420L-1317, 420L-1318, 420L-1319, 420L-1320, 420L-1321, 420L-1322, 420L-1344, 420L-1345, 420L-1346, 420L-1347, 420L-1348, 420L-1349, 420L-1351, 420L-1352, 420L-1353, 420L-1354, 420L-1355, 420L-1370, 420L-1403, 420L-1404, 420L-1409, 420L-1422 and 420L-1426.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product sent to distributors in Argentina, Austria, Chile, Denmark, Dubai, France, Greece, Hong Kong, India, Italy, Japan, Korea, Malaysia, Norway, South Africa, Spain, Sweden and United Kingdom. No US distribution.
  • Product Description
    Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew 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