Recall Z-0782-2007 ยท FWF Camera, Television, Endoscopic, Without Audio
Smith & Nephew, Inc Endoscopy Division
SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
| Date | May 5, 2007 (initiated Jan 19, 2007) |
| Status | Terminated |
| Reason | Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT) |
| Root cause | Other |
| Action | Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return. |
| Quantity | 25 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, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Turkey and U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.