Medical equipment, implants, and diagnostic devices
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Roche Diagnostics Operations
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.
Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.
CooperSurgical
There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.
Skytron, Div. The KMW Group
Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image.
Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Nuvasive Specialized Orthopedics
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Siemens Medical Solutions USA
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Medline Industries
The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Skytron, Div. The KMW Group
VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.