Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera system is configured to
FDA device recall Z-1479-2012 · posted 2012-05-01 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- May experience intermittent loss of video due to a defective board component
- Action taken
- Smith & Nephew Endoscopy Division sent an "URGENT PRODUCT RECALL 1st NOTIFICATION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and to complete and return the bottom portion of the letter via fax at 405-917-8650. Contact the firm at 405-917-8556 for questions regarding this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 239 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and UK Asia-
- Date initiated
- 2012-03-29
- Date posted
- 2012-05-01
- Date terminated
- 2016-01-13
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 560 HIGH DEFINITION CAMERA SYSTEM (K070266) | Smith & Nephew, Inc. | 2007-02-22 |