7 results
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11ms
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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
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
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
FDA Recall
Open, Classified
·Hamilton Co·Product code JQW·January 15, 2021
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
FDA Recall
Open, Classified
·Neotract Inc·Product code PEW·June 24, 2022