GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Class I - Dangerous
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Class I - Dangerous
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
Cook Medical
Class I - Dangerous
A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
Class I - Dangerous
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Class I - Dangerous
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
Class I - Dangerous
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Class I - Dangerous
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Dirty Lens May Cause Invalid or False Positive Results
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
Class I - Dangerous
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Class I - Dangerous
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Class I - Dangerous
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results