Medical equipment, implants, and diagnostic devices
bioMerieux
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
Fujifilm Medical Systems U.S.A.
Fujifilm is recalling multiple endoscopes after a retrospective review.
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 connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
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.
For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief¿ products to prevent potential contamination. .
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 connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
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.
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 connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
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.