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

FDA device recall Z-2039-2014 · posted 2014-07-10 · Terminated

Recall details

Recalling firm

Karl Storz Endoscopy

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.

Action taken

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

Status

Terminated

Product code

LMD

Quantity affected

968 units

Distribution

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, T

Date initiated

2014-06-25

Date posted

2014-07-10

Date terminated

2015-01-13

Location

El Segundo, CA