Battery Charging Station; Model: 0998-00-0802;

FDA device recall Z-1587-2026 · posted 2026-03-19 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DSP

Quantity affected

28 units (20 US, 8 OUS)

Distribution

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.

Date initiated

2026-02-06

Date posted

2026-03-19

Location

Mahwah, NJ

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