FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0782-2007
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division
- Product
- SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
- Status
- Terminated
- Initiated
- 2007-01-19
- Posted
- 2007-05-05
- Terminated
- 2008-09-02
- 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 United Kingdom.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWF
- Firm FEI
- 1643264
- Firm city
- Oklahoma City
- Firm state
- OK
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28