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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
There was an increase in complaints related to tip breaks and wobble/vibration.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.