Zoll Lifecor Corporation Recalls
Showing 1-4 of 4 recalls
Model 4000 Monitor component of the LifeVest Wearable Defibrillator
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.
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.
Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
The charging circuit will not shut down properly.
Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.
Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.
Patients currently using the LifeVest should continue to do so while the product removal is underway. Advisory notices will be sent via first class mail 9/14/2007 to all active patients using the LifeVest device. Product replacements began on 8/31/07 by shipping out revised battery packs for new patient use. Shipments of new battery packs will continue based on production capacity and material availability. Any patients expected to be using the device longer than 5 months will be provided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the same shipping box.
Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.
The electrodes do not properly release conductive gel
Patients currently using the product should continue to do so while the product removal is underway. Product replacements will begin with the belts currently in the possession of the sales reps. By replacing these first any new patients will be receiving new or refurbished belts with new Therapy Electrodes that have not been exposed to methanol. As patients complete their use of the LifeVest and return their device to the firm the belt's refurbishment process will include replacement of all 3 Therapy Electrodes. The firm expects this process to be completed in approximately 3 months based on the average use of time and current production capabilities. The process may take an additional month for devices distributed overseas. Physicians with active patients were notified via letter sent certified mail on 5/3/07. Long term use patients (patients using the device longer than 3 months) will be notified of the product removal via telephone and follow up letter. Each long term patient will be provided with a replacement belt. They will be instructed to return their existing belt in the same shipping box. Due to the low residual risk no notification is planned for short term use patients. Prescribing physicians have the option to notify their patients if they choose to do so.