EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Reported: November 9, 2022 Initiated: September 30, 2022 #Z-0151-2023
Product Description
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Reason for Recall
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 7 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.. Recalled by Boston Scientific Corporation. Units affected: 7 devices.
Why was this product recalled? ▼
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 9, 2022. Severity: Moderate. Recall number: Z-0151-2023.
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