Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
FDA device recall Z-0082-2012 · posted 2011-10-21 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- HD1200 camera heads may cause image issues
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 15 units
- Distribution
- Nationwide Distribution (USA) including the states of: MI, NH, OK.
- Date initiated
- 2011-09-23
- Date posted
- 2011-10-21
- Date terminated
- 2016-02-16
- Location
- Andover, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPIC CAMERA TC804/C4 (K014158) | World of Medicine Lemke GmbH | 2002-03-14 |