🏥 Medical Devices Class I - Dangerous
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
All Recalls
95,083 total recalls in our database
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Arrow International
🏥 Medical Devices Class I - Dangerous
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.
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 Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Merge Healthcare
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
🏥 Medical Devices Class I - Dangerous
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
XARIO 200 TUS-X200 diagnostic ultrasound system
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
APLIO 500 TUS-A500 diagnostic ultrasound system
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Lot was not functioning properly and not exhibiting the correct physical properties.
🏥 Medical Devices Class I - Dangerous
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Alaris Pump Module model 8100
CareFusion 303
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.