Battery Charging Station; Model: 0998-00-0802;
Pending LLM rewrite. Source: FDA_DEVICE Z-1587-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Battery Charging Station; Model: 0998-00-0802;
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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