Class 2 Device Recall LifeVest Wearable Defibrillator

• Date Initiated by Firm: September 24, 2010
• Date Posted: December 16, 2010
• Recall Status: Terminated on July 05, 2012
• Recall Number: Z-0625-2011
• Recall Event ID: 56957
• PMA Number: P010030
• Product Classification: Wearable automated external defibrillator - Product Code MVK
• Product: Model 4000 Monitor component of the LifeVest Wearable Defibrillator
• Code Information: product number 10A0988-A01; Serial number: 07000178, 07000196, 07000199, 07000202, 07000205, 07000211, 07000214, 07000223, 07000232, 07000241, 07000250, 07000265, 07000271, 07000289, 07000298, 07000301, 07000304, 07000307, 07000310, 07000313, 07000316, 07000325, 07000337, 07000343, 07000349, 07000355, 07000361, 07000373, 07000388, 07000397, 07000400, 07000409, 07000415, 07000427, 07000433, 07000436, 07000439, 07000448, 07000463, 07000466, 07000469, 07000472, 07000490, 07000496, 07000505, 07000511, 07000517, 07000520, 07000526, 07000529, 07000532, 07000538, 07000541, 07000574, 07000604, 07000628, 07000637, 07000646, 07000655, 07000658, 07000661, 07000697, 07000721, 07000730, 07000766, 07000769, 07000772, 07000784, 07000793, 07000796, 07000805, 07000808, 07000811, 07000820, 07000826, 07000838, 07000847, 07000853, 07000862, 07000877, 07000880, 07000883, 07000895, 07000898, 07000904, 07000913, 07000916, 07000919, 07000928, 07000937, 07000940, 07000943, 07000946, 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07003460,
• Recalling Firm/ Manufacturer: Zoll Lifecor Corporation; 121 Freeport Rd; Pittsburgh PA 15238-3411
• For Additional Information Contact: Jason Whiting; 412-826-9300
• Manufacturer Reason for Recall: The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.
• FDA Determined Cause: Other
• Action: Zoll Life Vest contacted patients that are expected to be in the device more than 60 days by letter and phone to arrange replacement monitors. Instructions for the return of the recalled monitor accompany the replacement monitor The firm will also contact the prescribing physician via telephone for long-term use patients to inform the physician of this voluntary recall and to assist in contacting any patients the firm was unable to reach by telephone. Zoll Life Vest can be contacted at 1-800-543-3267 about this recall.
• Quantity in Commerce: 494 units
• Distribution: Nationwide Distribution: Throughout the US. including the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MVK