🏥 Medical Devices • 15,809 recalls
Beckman Coulter
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Fujifilm Medical Systems U.S.A.
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
Fresenius Medical Care Holdings
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.
Fresenius Medical Care Holdings
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.
Siemens Medical Solutions USA
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care Holdings
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.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Cook Medical
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.
Fresenius Medical Care Holdings
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.
Fresenius Medical Care Holdings
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Fresenius Medical Care Holdings
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.