FDA Device recall Z-1587-2026
Battery Charging Station
- FDA Device
- Class III
- ongoing
- Published 2026-03-25
On 2026-03-25 the FDA classified a Class III recall of Battery Charging Station by Datascope, citing 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 ha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1587-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-02-06 |
| Published | 2026-03-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Datascope |
| Distribution | US |
Product
Battery Charging Station; Model: 0998-00-0802;
Reason
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.
Identifiers
| code_info | Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 21001…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1587-2026%22
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