FDA Medical Device Recalls (openFDA)
Zoll Manufacturing Corp.: 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.
- Recall number
- Z-0353-2018
- Recalling firm
- Zoll Manufacturing Corp.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-09-12
- Posted
- 2018-01-14
- Terminated
- 2021-08-10
- Reason
- Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
- Root cause
- Other
- Action
- 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.
- Quantity
- 33,670 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- ["P010030"]
- Product code
- MVK
- Firm FEI
- 3008642652
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28