Recall Z-0782-2007
Smith & Nephew, Inc Endoscopy Division · initiated January 19, 2007
Product
SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
Codes / lots: 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.
Reason for recall
Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
FDA-determined cause: Other
Action taken
Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.
Details
- Recall number
- Z-0782-2007
- Initiated
- January 19, 2007
- Posted by FDA
- May 5, 2007
- Terminated
- September 2, 2008
- Product code
- FWF – Camera, Television, Endoscopic, Without Audio
- 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 United Kingdom.
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0781-2007 | SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France…Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for… | 01/19/2007Terminated |