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FDAFDA · Food and drugs·Recall number Z-2039-2014

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

Published July 16, 2014 · Recall initiated: June 25, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Karl Storz Endoscopy
Distributor
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.
Lot
Serial Numbers: 20110322-01 HLS-20110706-01 HLS-20110315-03 MLS-20101208-01 MLS-20101101-01 MLS-20130418-22 MLS-20130715-03 MLS-20130514-06 MLS-20130514-13 MLS-20130514-14 MLS-20130514-09 MLS-20130514-18 MLS-20130514-19 MLS-20130514-16 MLS-20130514-11 MLS-20130514-08 MLS-20130514-15 MLS-20130514-17 HLS-20130523-02 HLS-20130523-04 MLS-20130514-07 HLS-20130523-03 MLS-20130715-04 MLS-20130514-12 MLS-20130514-10 MLS-20110609-01 MLS-20110603-02 MLS-20110603-01 MLS-20110527-02 MLS-20110531-01 MLS-20110531-02 MLS-20110601-01 MLS-20110601-03 MLS-20140411-01 MLS-20130418-18 MLS-20130418-13 HLS16-20130128-04 HLS16-20130128-03 HLS16-20130128-01 HLS16-20130128-02 MLS-20140424-02 MLS-20130514-02 MLS-20130418-21 MLS-20120924-03 LLS-20111003-03 MLS-20111011-03 MLS-20110920-03 MLS-20120117-14 MLS-20120523-03 MLS-20120905-02 LLS-20121112-04 MLS-20130322-01 MLS-20120713-05 MLS-20110713-04 MLS-20110629-01 MLS16-20131028-01 MLS-20120208-01 HLS24-20130823-01 LLS-20120103-03 MLS-20111005-08 HLS-20120118-03 HLS-20120112-01 MLS-20120910-05 MLS-20121010-01 MLS-20120910-03 MLS-20120910-01 MLS-20120830-01 MLS-20120920-03 MLS-20120920-05 MLS-20120920-06 MLS-20120920-07 MLS-20120808-01 MLS-20121010-02 MLS-20121008-02 MLS16-20130708-06 MLS-20120207-04 LLS-20130109-01 MLS-20120213-02 MLS-20120213-03 MLS-20120215-01 MLS-20120215-03 MLS-20120306-02 MLS-20120329-01 HLS-20120207-01 MLS-20120301-01 MLS-20120319-01 MLS-20120313-01 MLS-20120104-03 LLS-20120430-02 MLS-20120511-02 MLS-20120523-02 MLS-20120618-01 MLS-20120301-02 LLS-20120615-01 LLS8-20121024-01 MLS-20120703-07 MLS16-20130927-01 MLS-20121231-01 MLS-20130418-01 MLS-20130405-01 MLS-20130405-10 MLS-20130405-08 20110314-02 HLS24-20130923-01 MLS16-20130923-03 LLS8-20140523-01 HLS24-20130923-02 HLS24-20130826-01 MLS16-20130823-01 LLS8-20130726-04 HLS24-20130809-01 LLS-20120103-12 LLS-20111207-03 LLS-20120103-04 LLS-20111227-02 MLS-20121231-07 MLS-20130418-09 LLS-20120427-03 20110211-01 MLS-20130418-08 MLS-20130418-15 LLS-20110315-01 LLS-20110309-01 HLS24-20130923-03 HLS32-20131206-01 LLS-20120517-05 LLS-20140307-01 LLS-20120419-01 LLS-20120409-01 LLS-20120404-01 LLS-20140307-02 MLS-20110502-03 20110309-02 MLS-20110502-02 MLS-20110506-01 MLS-20110510-02 MLS16-20140328-01 LLS8-20140314-01 MLS-20130726-03 MLS-20130726-02 MLS-20130418-11 MLS-20130418-14 MLS-20130725-01 MLS-20130726-04 MLS-20130726-01 MLS-20130725-02 LLS-20120420-05 MLS-20120523-04 LLS-20120427-05 MLS-20120703-12 MLS-20120703-10 MLS-20120703-09 MLS-20120703-06 MLS-20120703-04 MLS-20120703-03 MLS-20120703-02 MLS-20120703-01 MLS-20120629-01 20110308-01 20110208-01 20110405-06 20110405-04 20110405-02 MLS16-20130214-04 MLS16-20130329-01 MLS16-20130329-04 MLS16-20130214-01 MLS16-20140428-01 MLS16-20130329-03 MLS16-20130923-01 MLS16-20131028-02 20110217-06 MLS-20111011-04 20110217-01 HLS16-20121108-01 HLS16-20121108-07 MLS-20111212-01 MLS-20120501-01 MLS-20120813-04 MLS-20120326-01 MLS-20120306-01 MLS-20120227-01 MLS-20120403-01 MLS-20120419-01 MLS-20120713-04 MLS-20120713-06 MLS-20120713-07 MLS-20120904-02 MLS-20120813-02 MLS-20120716-01 MLS-20120813-01 HLS32-20130401-01 MLS-20111027-02 HLS24-20140407-02 HLS-20130313-02 HLS32-20130906-01 HLS32-20130906-02 MLS-20130329-01 HLS24-20140328-01 HLS24-20140124-02 HLS24-20140203-01 MLS-20130322-02 MLS-20121213-21 MLS-20130405-02 MLS-20130405-04 MLS-20130418-10 MLS-20130418-03 MLS-20130418-20 MLS-20130418-19 MLS-20130514-05 MLS-20130514-04 HLS24-20140213-01 HLS24-20140124-01 MLS-20120904-01 MLS-20130226-01 20110315-04 MLS-20110927-02 MLS-20110510-03 MLS16-20131018-01 HLS24-20130703-01 MLS-20110630-01 MLS16-20130729-01 LLS8-20131016-05 MLS16-20130923-02 HLS24-20130729-01 MLS-20121016-02 MLS-20121016-01 LLS-20110713-05 MLS-20110713-03 MLS-20110622-04 LLS-20110411-04 LLS-20120224-01
Risk classification
Class II
Area (FDA)
device
Country
United States

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