13 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·April 5, 2023
BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·September 6, 2023
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 6, 2025
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
FDA Recall
Open, Classified
·Zimmer Surgical Inc·Product code FZW·January 2, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·June 17, 2024
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·November 4, 2021
Medtronic InterStim Ground Pad REF 041826
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·July 6, 2023
Enhanced Verify Evaluation Handset (CFN HH90130FA)
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·April 3, 2025
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·May 15, 2019
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
FDA Recall
Open, Classified
·Molnlycke Health Care, Inc·Product code FZW·April 24, 2017
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·February 28, 2022
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
FDA Recall
Open, Classified
·PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany·Product code IYE·February 8, 2024
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)
FDA Recall
Open, Classified
·PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany·Product code IYE·June 7, 2023