BEUDAMED
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    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

    FDA Recall
    Open, Classified ·Hologic Inc·Product code OTE·August 19, 2024

    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·March 24, 2026

    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·March 20, 2026

    Allia IGS 5 Pulse angiographic X-ray system

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OWB·April 20, 2026

    Allia IGS 3 Pulse angiographic X-ray system

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OWB·April 20, 2026

    Allia Moveo angiographic X-ray system

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OWB·April 20, 2026

    Allia IGS Pulse angiographic X-ray system

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OWB·April 20, 2026

    Allia IGS 7 Pulse angiographic X-ray system

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OWB·April 20, 2026

    Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MWI·December 6, 2024

    GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Medical Systems SCS·Product code LLZ·May 8, 2026

    Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code FMZ·May 1, 2026

    Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code FMZ·May 1, 2026

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·April 5, 2024

    Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code FMZ·May 1, 2026

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764, l) 5514418-01166521, m) 5514418-01180241, n) 5514418-01181177, o) 5514418-01183037, p) 5514418-01184556, q) 5514418-01184557, r) 5514418-01185805, s) 5514418-01186277, t) 5514418-01187473, u) 5514418-01188453, v) 5514418-01190677, w) 5514418-01192703, x) 5514418-01192705, y) 5514418-01203242, z) 5514418-01206279, aa) 5514418-01208248, bb) 5514418-01212670, cc) 5514418-01215947, dd) 5514418-01218564, ee) 5514418-01222489, ff) 5514418-01222812, gg) 5514418-01223831, hh) ii) 5514418-01228038, ii) 5514418-01228181, jj) 5514418-01230534, kk) 5514418-01235322, ll) 5514418-01236388, mm) 5514418-01244357, nn) 5514418-01250690, oo) 5514418-01250761, pp) 5514418-01256439; monitor, physiological, patient

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·April 5, 2024

    Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

    FDA Recall
    Open, Classified ·Guangzhou Improve Medical Instruments Co., Ltd. NO.·Product code FMI·September 22, 2017

    Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

    FDA Recall
    Open, Classified ·Teleflex Medical·Product code FMI·October 8, 2019

    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Recall
    Open, Classified ·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025

    Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

    FDA Recall
    Open, Classified ·C.A. Greiner & Sohne Gesellschaftmbh Greiner St. # 70 Kremsmunster Austria·Product code FMI·July 27, 2020

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc·Product code FMI·July 27, 2021