Medical equipment, implants, and diagnostic devices
Roche Molecular Systems
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Smiths Medical ASD
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Medtronic Sofamor Danek USA
Engraving on implants may not match what is listed on the pouch labels.
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
Smiths Medical ASD
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Smiths Medical ASD
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Under certain conditions, there is a risk for a false negative result.
Red Medical Supplies
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.
Intuitive Surgical
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Abbott Molecular
There is a potential for false positive results.
Abbott Molecular
There is a potential for false positive results.
Red Medical Supplies
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.
Red Medical Supplies
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.
W L Gore & Associates
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Abbott Molecular
There is a potential for false positive results.