EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Reported: November 9, 2022 Initiated: September 30, 2022 #Z-0152-2023
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 142 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 MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.. Recalled by Boston Scientific Corporation. Units affected: 142 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-0152-2023.
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