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Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.

FDA device recall Z-2148-2012 · posted 2012-08-06 · Terminated

Recall details

Recalling firm
Berchtold Corp.
Reason for recall
Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss.
Action taken
BERCHTOLD Corporation sent a letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. BERCHTOLD will replace the customer's cameras at no cost to the customer. Customers with questions should call 843-569-6100, ext 322. For questions regarding this recall call 843-569-6100.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
FWH
Quantity affected
17 cameras
Distribution
Nationwide Distribution including FL, MI, MS, and NH.
Date initiated
2012-07-10
Date posted
2012-08-06
Date terminated
2013-06-06
Location
N Charleston, SC

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