Medical equipment, implants, and diagnostic devices
Otto Bock Healthcare Product
Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.
Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg
Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
Becton, Dickinson and Company, BD Biosciences
Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.
Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.
Sunrise Medical (US)
Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Advanced Sterilization Products
Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.
The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
Arrow International
the catheter peel-away component hub tabs may prematurely detach. One injury reported.
Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
RAYSEARCH LABORATORIES AB
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.
The device may have improper screw hole placement due to inaccurate location of the index line.
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.