The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patientยฟs condition and delayed or missed life sustaining patient treatment
Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.
Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.
During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Hewitt Machine & Manufacturing Inc., of Nicollet, Minn.
๐ Consumer Products Class II - Moderate
The top and bottom roller chains in the winch can break, causing the winch and marine lift to fail. This can pose an injury hazard to the user or bystander.
The filler cap at the top of the unit can crack and allow steam to escape, posing a risk of burns to the user. In addition, the cap can pop off unexpectedly as a result of pressure buildup, posing a risk of injury to a bystander.