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Terminated

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

FDA Recall Z-2148-2012 · Posted 2012-08-06

Recalling FirmBerchtold Corp.
Recall StatusTerminated
Product CodeFWH
Date Initiated2012-07-10
Date Terminated2013-06-06
Product Quantity17 cameras

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.

Firm Action

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

Distribution Pattern

Nationwide Distribution including FL, MI, MS, and NH.

Official Source

View FDA Recall →

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

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