FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc Endoscopy Division: SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
- Recall number
- Z-0781-2007
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division
- Product
- SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 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
- 77 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: 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.
- 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