i-STAT cTnI cartridge
Abbott Point Of Care
Class I - Dangerous
i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Villa Sistemi Medicali S.P.A.
Class I - Dangerous
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Class I - Dangerous
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Class I - Dangerous
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Class I - Dangerous
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.
STANLEY BLACK & DECKER
Class I - Dangerous
The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit (1 mW) established for Class II lasers. These products would be more appropriately classified into laser Class IIIa (IEC Laser Class IIIR).
Class I - Dangerous
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Class I - Dangerous
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.
Class I - Dangerous
Reports of pressure relief manifold venting gas below the standard pressure.
Class I - Dangerous
The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological deficit/dysfunction
Class I - Dangerous
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Lamicel 10PK 10MM INTL
Medtronic Xomed
Class I - Dangerous
Routine sterilization dose does not meet the required Sterility Assurance Level.
STA SYSTEM CONROL N + P (ref. 00678)
Diagnostica Stago
Class I - Dangerous
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.
Class I - Dangerous
Reports of pressure relief manifold venting gas below the standard pressure.
Class I - Dangerous
Reports of pressure relief manifold venting gas below the standard pressure.
Lamicel 20PK 5MM INTL
Medtronic Xomed
Class I - Dangerous
Routine sterilization dose does not meet the required Sterility Assurance Level.
STA UNICALIBRATOR (ref. 00675)
Diagnostica Stago
Class I - Dangerous
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.