Medical equipment, implants, and diagnostic devices
Merge Healthcare
If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
Toshiba American Medical Systems
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Toshiba American Medical Systems
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
The Reusable Oscor ATAR extension cables could separate from the connector during use.
Lot was not functioning properly and not exhibiting the correct physical properties.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
CareFusion 303
There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Arrow International
Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.