Model 4000 Monitor component of the LifeVest Wearable Defibrillator

FDA device recall Z-0625-2011 · posted 2010-12-16 · Terminated

Recall details

Recalling firm

Zoll Lifecor Corporation

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.

Action taken

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

Status

Terminated

Product code

MVK

Quantity affected

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,

Date initiated

2010-09-24

Date posted

2010-12-16

Date terminated

2012-07-05

Location

Pittsburgh, PA