Infusion Pumps

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.

Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.

The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.

Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.

Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.

Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.

Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.

A diode was inadvertently not assembled into the system, which may result in coil overheating

Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.

Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.

It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.

The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury.