Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Chest drains have a missing o-ring
Class I - Dangerous
Catheters may not meet antimicrobial specification
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
Covidien
Class I - Dangerous
Catheters may not meet antimicrobial specification
Class I - Dangerous
Catheters may not meet antimicrobial specification
Class I - Dangerous
Catheters may not meet antimicrobial specification
Class I - Dangerous
Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.
Class I - Dangerous
Catheters may not meet antimicrobial specification
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
Covidien
Class I - Dangerous
Catheters may not meet antimicrobial specification
Class I - Dangerous
Catheters may not meet antimicrobial specification
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, 21762-111-36H.
Sechrist Industries
Class I - Dangerous
Sechrist Industries is recalling the Sechrist Low Profile Wheeled Stretcher because it may experience an unexpected incline angle during the height adjustment of the Low Profile Wheeled Stretcher when lifting the patient upward or when lowering the Wheeled Stretcher to a height at which the patient can be loaded/unloaded.
Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps.
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Siemens Medical Solutions USA
Class I - Dangerous
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Siemens Healthcare Diagnostics
Class I - Dangerous
D50 and D51 diagnostic error codes are not functional.
Class I - Dangerous
Catheters may not meet antimicrobial specification
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Class I - Dangerous
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
Class I - Dangerous
Catheters may not meet antimicrobial specification