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Terminated

Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.

FDA Recall Z-2039-2014 · Posted 2014-07-10

Recalling FirmKarl Storz Endoscopy
Recall StatusTerminated
Product CodeLMD
Date Initiated2014-06-25
Date Terminated2015-01-13
Product Quantity968 units

Reason for Recall

KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.

Firm Action

Storz sent an Safety Alert letter dated June 25, 2014, to all customers who purchased the Essential NEO. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Acknowledgement/Response Form with contact information and return to KARL STORZ. Customers with questions are instructed to contact KARL STORZ' Technical Support Department at (800) 421-0837, option 3, then option 4.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, District of Columbia, DE, FL, GA, HI, IA, IL, IN, KY, LA, MX, MS, MD, MI, MA, MO, MN. NM, NV, NJ, NY, NC, NE, OK, OH, PA, SC, SD, TX, UT, VA, WI and WA., and Internationally to Canada.

Official Source

View FDA Recall →

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

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