Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
This recall has been terminated (originally issued October 21, 2011).
- Recall Initiated
- September 23, 2011
- Posted
- October 21, 2011
- Terminated
- February 16, 2016
- Recall Number
- Z-0082-2012
- Quantity
- 15 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
HD1200 camera heads may cause image issues
Distribution
Nationwide Distribution (USA) including the states of: MI, NH, OK.
Lot / Code Info
S/N: DDQ00051, DDQ00052, DDQ00057 DDQ00064, DDQ00068, DDQ00070 DDQ00071, DDQ00080, DDQ00083 DDQ00085, DDQ00093, DDQ00094 DDQ00096, DDQ00104, DDQ00108
Root Cause
Process design
Action Taken
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 endo.andreturns@smith-nephew.com. For questions call 405-917-8556.