Datascope Corp. recalls Battery Charging Station
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Battery Charging Station; Model: 0998-00-0802;
Lot / code information
- Model
- 0998-00-0802
- UDI
- 10607567111964
- Serial #
200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI — +22 moreShow all
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
What the firm is doing
On February 6, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken by the customer: Our records indicate that you may have one or more Battery Charging Station(s) in your facility. Please forward this information to all current Battery Charging Station users within your facility. " If you are currently using one of the affected Battery Charging Stations, please follow the instructions in the Battery Charging Instructions section of this letter. " Complete and sign the attached Response Form to acknowledge that you have received and understand this notification. Return the completed form to recallresponses.grc@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
DistributionShow detailsHide
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.
Use of the product is not likely to cause adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1587-2026
- FDA 510(k) clearance · K112372The device's official FDA premarket clearance record
- FDA device classification · DSPOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.3535The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Datascope Corp.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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