Z-0625-2011

Model 4000 Monitor component of the LifeVest Wearable Defibrillator

Name: Z-0625-2011 Model 4000 Monitor component of the LifeVest Wearable Defibrillator
Creator: Zoll Lifecor Corporation
Published: 2010-09-24
License: https://open.fda.gov/license/

ZOLL Manufacturing Corporation / initiated 2010-09-24 / Terminated

FDA source

Zoll Lifecor Corporation began a recall of Model 4000 Monitor component of the LifeVest Wearable Defibrillator on 2010-09-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0625-2011
Status: Terminated
Initiated: 2010-09-24
Posted: 2010-12-16
Terminated: 2012-07-05
Recalling firm: ZOLL Manufacturing Corporation
Product: Model 4000 Monitor component of the LifeVest Wearable Defibrillator
Product code: MVK Wearable Automated External Defibrillator
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 root 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.
Product codes and lots: 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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Product code MVK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)