🏥 Medical Devices • 15,809 recalls
SIGHT DIAGNOSTICS
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
Kits contain leaking bottles of isopropyl alcohol
Kits contain leaking bottles of isopropyl alcohol
NordicNeuroLab AS
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
MEDLINE INDUSTRIES, LP - SPT
Kits contain leaking bottles of isopropyl alcohol
Intuitive Surgical
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
The device may potentially cause a fire, leading to a safety risk.
Kits contain leaking bottles of isopropyl alcohol
Kits contain leaking bottles of isopropyl alcohol
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
MEDLINE INDUSTRIES, LP - SPT
Kits contain leaking bottles of isopropyl alcohol
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Intuitive Surgical
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
MEDLINE INDUSTRIES, LP - SPT
Kits contain leaking bottles of isopropyl alcohol
Becton Dickinson & Company
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
Aesculap Implant Systems
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Becton Dickinson & Company
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.