Datascope Corp.: Battery Charging Station; Model: 0998-00-0802;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Datascope Corp.
- Product
- Battery Charging Station; Model: 0998-00-0802;
- Reason / hazard
- The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway.
- Recall initiated
- 2026-02-06
- Code info
- Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;
- Product quantity
- 28 units (20 US, 8 OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mahwah
- State
- NJ
- Country
- United States
- Event id
- 98432
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