Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2467-2008

OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint...

STRYKER Communications, Inc. / initiated 2008-04-01 / Terminated / root cause: manufacturing process

Stryker Communications Corp began a recall of OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint Infinity 1, Switchpoint Infinity 2, and... on . The reason FDA records is "Product at times experiences intermittent signal loss due to electromagnetic interference". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2467-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STRYKER Communications, Inc.
Product
OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint Infinity 1, Switchpoint Infinity 2, and Switchpoint Element. The OPHIT Optical Digital Visual Interface (DVI) Extender is a converter and transmitter for copper and fiber optic DVI signals.
Product code
GCJ Laparoscope, General & Plastic Surgery
Reason for recall
Product at times experiences intermittent signal loss due to electromagnetic interference.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Firm sent notification letters to consignees on 4/1/2008. The letter informed the customers. The firm plans to replace the affected product. Contact Stryker at !-972-410-7100 for assistance.
Quantity in commerce
7,599 units
Distribution
Nationwide
Product codes and lots
All lots produced between 1/5/2006 and 12/15/2007.