HeartStart XL+ battery charge time to 100% capacity at 35ÂŋC (95ÂŋF) is slightly longer than the specified 3 hour duration as stated in the labeling
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Fresenius Medical Care Holdings
Class I - Dangerous
Dialysate Port Leak During Priming of the Dialyzers
Wireless Link may be unable to transmit data when configured for a specific data flow.
Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
Siemens Medical Solutions USA
Class I - Dangerous
During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Inner spherical radius of the shell is undersized.
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Fresenius Medical Care Holdings
Class I - Dangerous
Dialysate Port Leak During Priming of the Dialyzers
Class I - Dangerous
The tracheal tube can kink during patient use.
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Fresenius Medical Care Holdings
Class I - Dangerous
Dialysate Port Leak During Priming of the Dialyzers
Class I - Dangerous
The tracheal tube can kink during patient use.
Class I - Dangerous
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Class I - Dangerous
The tracheal tube can kink during patient use.
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Fresenius Medical Care Holdings
Class I - Dangerous
Dialysate Port Leak During Priming of the Dialyzers
Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wall mount units were delivered with FOCUS X-ray machines that had not been properly welded at our supplier. As a result of the incomplete welding operation, the wall mount unit on the FOCUS X-ray unit may not properly support the unit as expected, which could cause the unit to drift. Depending on the extent of the shortened or missing welds, there is also a possibility that the wall mount unit will fail to support the weight of the unit, resulting in the FOCUS X-ray unit falling unexpectedly from its mounted position.
Class I - Dangerous
Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
Philips Medical Systems
Class I - Dangerous
HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers
A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.
Class I - Dangerous
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Class I - Dangerous
The tracheal tube can kink during patient use.