Loading...
Loading...
Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
There is the potential that the silicone implant may contain foreign material
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Natus received two complaints of left side labeling show impedance for right side.
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Potential for faulty devices as a result of depleted batteries.