Recall Z-0152-2023— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2022-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.. Reason: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-30
- Firm location
- Saint Paul, MN, United States
Product description
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Reason for recall
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.