BEUDAMED
    FDA Recall Open, Classified

    CS100 IABP. Software Version CS100 IABP Q.01.

    Recall: Z-1486-2026 · Initiated January 23, 2026

    Recall

    Recall Number
    Z-1486-2026
    Event Number
    98189
    Firm
    Datascope Corp.
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 23, 2026
    Posted
    March 3, 2026
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    CS100 IABP. Software Version CS100 IABP Q.01.

    Reason

    The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notice dated January 2026 was mailed to consignees. The notification informs consignees of an updated battery specification to be updated in the IFU. Consignees are to forward the notice to all users in their facility, confirm users are aware of the IFU clarifications, and complete and return the provided Response Form. If product was further distributed, the provided notification is to be forwarded to them. Consignees with any questions should contact Datascope/Getinge Cusotmer Support at 1-888-943-8872, options 4, 2, 1.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador , Estonia, France, Georgia, Germany, Ghana, Greece, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.

    Quantity

    10,897 units