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Recall Observatory FDA recall evidence

Device product

Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.

Z-1340-2013

March 18, 2013

Class II

Product summary

Firm
Linvatec Corp. dba ConMed Linvatec
Event
Event 64647
Status
Terminated
Classification
Class II
Quantity
267 units
Official record key
device-enforcement:Z-1340-2013

Official wording

Reason: The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.

Code information: VP1600

Distribution pattern: Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    anomaly between the software