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Terminated

Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories

FDA Recall Z-0082-2012 · Posted 2011-10-21

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeGCJ
Date Initiated2011-09-23
Date Terminated2016-02-16
Product Quantity15 units

Reason for Recall

HD1200 camera heads may cause image issues

Firm Action

Smith Nephew sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to [email protected]. For questions call 405-917-8556.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution (USA) including the states of: MI, NH, OK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014158ENDOSCOPIC CAMERA TC804/C4World of Medicine Lemke GmbH · 2002-03-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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