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Terminated

Model 4000 Monitor component of the LifeVest Wearable Defibrillator

FDA Recall Z-0625-2011 · Posted 2010-12-16

Recalling FirmZoll Lifecor Corporation
Recall StatusTerminated
Product CodeMVK
Date Initiated2010-09-24
Date Terminated2012-07-05
Product Quantity494 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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