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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Potential for coils to heat up and harm patients (burn).
Potential for coils to heat up and harm patients (burn).
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Potential for coils to heat up and harm patients (burn).
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Expired Products distributed to customers
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.