Z-1979-2013 Class II Terminated
FDA device recall Z-1979-2013 was initiated by Boston Scientific CRM Corp on July 15, 2013 and is designated Class II. Reason for recall: Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which r… The recall status is terminated (terminated November 12, 2013). Affected quantity: 1 (4 devices were implanted and are not part of this action).
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2013
- Initiation Date
- July 15, 2013
- Termination Date
- November 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 (4 devices were implanted and are not part of this action)
Product Description
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Reason for Recall
Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufactu
Distribution Pattern
US distribution in the state of Tennessee.
Code Information
Serial # 108063