Medical equipment, implants, and diagnostic devices
MEDLINE INDUSTRIES, LP - Northfield
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Meridian Bioscience
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
Potential for pilot balloon non-inflation or cuff non-deflation.
Getinge Usa Sales
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Johnson & Johnson Surgical Vision
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Getinge Usa Sales
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Getinge Usa Sales
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Future Diagnostics Solutions B.V.
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
Potential for pilot balloon non-inflation or cuff non-deflation.
Align Technology
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
CooperVision
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
Johnson & Johnson Surgical Vision
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Johnson & Johnson Surgical Vision
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.