9 results
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10ms
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Sources: EU EUDAMED, US FDA
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JSO·November 9, 2022
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JSO·November 9, 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
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
FDA Recall
Open, Classified
·Koven Technology, Inc.·Product code DPW·March 4, 2026
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code NPW·March 27, 2026
GEM FLOW COUPLER Monitor, PN 5156-00000-011
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DPW·June 19, 2023
FloPatch FP120, REF: FP120-FOT01-005
FDA Recall
Open, Classified
·Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Fourth Floor, Oneeleven
325 Front St W
Toronto Canada·Product code DPW·August 7, 2025
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
FDA Recall
Open, Classified
·Medistim Asa Okernveien·Product code DPW·September 26, 2025