Z-0782-2007

SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith...

Name: Z-0782-2007 SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith...
Creator: Smith & Nephew, Inc Endoscopy Division
Published: 2007-01-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2007-01-19 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc Endoscopy Division began a recall of SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810 on 2007-01-19. The reason FDA records is "Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0782-2007
Status: Terminated
Initiated: 2007-01-19
Posted: 2007-05-05
Terminated: 2008-09-02
Recalling firm: Smith & Nephew, Inc.
Product: SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
Product code: FWF Camera, Television, Endoscopic, Without Audio
Reason for recall: Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.
Quantity in commerce: 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.
Product codes and 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.

Product code FWF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)