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U.S. Department of Health and Human Services

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 Class 3 Recall
Lead Integrity Alert		see related information
Date Posted April 08, 2009
Recall Number Z-1172-2009
Product Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.
Code Information v1.0 software
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St. N.E.
Mounds View, Minnesota 55112
Reason for
Recall		 Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.
Action Between November 24 and December 9, 2008 US CRDM are responsible to hand deliver the consignee letter, a Medtronic "Urgent Patient Management Information," dated November 2008, to impacted physicians to make them aware of the issue and continue to promote and install LIA (by using the new LIA tipcard). For any physician listed that a confirmation sheet was not received by end of day, December 9, 2008, the letter was mailed to the physician on Dec 10, 2008. The letter described the issue and the product involved. The letter also gave recommendations and informed consignees in regard to a future update to the LIA software for EnTrust devices.
Quantity in Commerce 55,755
Distribution Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands.
 
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