—#51613

Product

SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.

FDA product code: FWF — Camera, Television, Endoscopic, Without Audio
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Smith & Nephew, Inc Endoscopy Division
Address: 76 S. Meridian Ave, Oklahoma City, Oklahoma 73107-6512

Distribution

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.

Timeline

Recall initiated: 2007-01-19
Posted by FDA: 2007-05-05
Terminated: 2008-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51613. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.