ClearanceBrief
Recall Z-2342-2012 ยท GWF Stimulator, Electrical, Evoked Response

Medtronic Xomed, Inc.

Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit

DateSep 10, 2012 (initiated Sep 27, 2010)
StatusTerminated
ReasonIn January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Root causeDevice Design
ActionThe firm, Medtronic USA, Inc., sent an "URGENT Product Recall Notification" letter dated September 27, 2010, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify their receipt of this notice and complete and sign the Product Replacement checklist form indicating that their sales representative has completed the replacement of their devices and fax to 1-651-367-8055. U.S. Customer Units - replacement kits with their contents will be provided to each Area Sales Manager (ASM) for each customer along w
Quantity464
DistributionWorldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norwa
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K083124NIM 3.0
Medtronic Xomed, Inc., Feb 27, 2009