Device product
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Z-0151-2023
Product summary
- Event
- Event 90985
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 devices
- Official record key
device-enforcement:Z-0151-2023
Official wording
Reason: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Code information: UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.
Distribution pattern: 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.
Derived failure modes
-
Device software or design
incorrect manufacturing date/timestamp within the software