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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Failed to meet USP minimum average value for knot pull (tensile) strength.
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.
The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.
Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.
Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).
Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
Product was distributed prior to approval or clearance from FDA.
On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturing functional testing. It was noted that a safety interlock within the lamp does not function in a reliable manner to shut down the system if the laser collimator is removed from the lamp while the system is operating. This is a potential safety hazard for anyone working on or nearby the lamp.
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.