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LifeVest Wearable Defibrillator Model 4000, Product Number… recallZ-0353-2018 · Zoll Manufacturing Corp. · initiated Sep 12, 2017

Class II Terminated All recalls posted in January 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zoll Manufacturing Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure

FDA root cause category: Other

What the company is doing

On September 14, 2017, ZOLL Manufacturing Corporation issued a patient safety alert notice dated September 12, 2017 to all active patients via courier service. As of November 2, 2017, a copy of this same patient Safety Alert notice is included with all current device shipments. The purpose of the communication is to revise the training patients received about the "Call for service" message. In certain cases, a "Call for service - Message Code 102" could mean that your LifeVest may not be able to deliver therapy if you need it. Users should call ZOLL immediately for a replacement LifeVest if a "Call for service - Message Code 102" appears on the screen. A replacement will be provided within 24 hours. Patients are instructed to continue using the LifeVest as prescribed by their physician. On January 8, 2019, Zoll Manufacturing Corporation issued Urgent Medical Device Correction notices to customers informing all that FDA approved a new software version for the ZOLL LifeVest 4000 that provides enhanced prominence and persistence of patient alerts when a "Call for service---Message Code 102" exists, instructing patients to call ZOLL immediately at 1-800-543-3267 for a replacement LifeVest. All new patients will receive a LifeVest with this new software revision. In addition, over the next 3.5 months, ZOLL will contact all current patients and exchange their monitor for one with this new software. Patients should continue to use the LifeVest as prescribed by their physician during the software rollout and no physician action is required. Customers with questions or concerns, please feel free to contact your ZOLL LifeVest representative or ZOLL Technical Services at 1-800-543-3267.

Recall details

Recall number
Z-0353-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 12, 2017
Posted by the FDA
Jan 14, 2018
Recalling firm
Zoll Manufacturing Corp.
Quantity
33,670 units
Product code
MVK
FDA submissions
P010030
Distribution
US Nationwide

Product description

LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

Code information (models, lots, serial numbers)

All Serial Numbers

Other devices under the same FDA submission

12 devices cleared under P010030 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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