105 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·August 11, 2025
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·January 27, 2023
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.
FDA Recall
Open, Classified
·Ge Healthcare·Product code RCC·May 8, 2020
Trilogy Evo Universal, Product number DS2000X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·July 26, 2021
Puritan Bennett 980 Series Ventilator
FDA Recall
Open, Classified
·Medtronic formerly Covidien Michael Collins Road, Mervue Ind. Park Galway Ireland·Product code CBK·March 25, 2022
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·December 7, 2022
Philips Garbin Ventilator, Model Number 1058180B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·December 7, 2022
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·May 29, 2024
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 1, 2023
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·July 16, 2024
Servo-n Ventilator System. Model Number: 6694800.
FDA Recall
Open, Classified
·Maquet Critical Care AB Rontgenvagen·Product code CBK·May 30, 2025
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
FDA Recall
Open, Classified
·Draeger Medical, Inc.·Product code CBK·January 23, 2023
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·May 1, 2023
Ventilator HAMILTON-C6, PN: 160021
FDA Recall
Open, Classified
·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·May 15, 2024
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·October 7, 2024
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·October 7, 2024