[pending] Battery Charging Station; Model: 0998-00-0802;
Pending LLM rewrite. Source: FDA_DEVICE Z-1587-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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