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Displaying 1 - 15 of 278 items.

Health alert or recall HL7 Outbound Results Interface
One client reported that HL7 files transferred to an outbound results interface (specific to one client) would sometimes contain more than one patient identifier, which could lead to results being assigned to the wrong patient in a third party system…
RecallHealth product recall | 2022-08-04
Health alert or recall Self-Righting Luer Slip And Lock Tip Caps
Baxter Corporation is issuing an urgent medical device recall for all non-expired lots of Self-Righting Luer Slip And Luer Lock Tip Caps listed due to the potential of the packaging seal not maintaining a sterile barrier for the tip caps. Recall start…
RecallHealth product recall | 2022-08-02
Health alert or recall Onetouch Reveal Mobile App (iOS/Andriod)
For some insulin mentor feature users, there is an overlap in their time-intervals. this causes the system to provide an incorrect insulin recommendation to the user and could potentially result in a deviation from the value the user should be getting…
RecallHealth product recall | 2022-08-02
Health alert or recall Philips Respironics recalls several models of CPAP and BiLevel PAP machines and mechanical ventilators
UPDATE (2022-07-27): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators Health Canada is providing an update on the progress of Philips Respironics’ (Philips) recall of several models of…
AlertPublic advisory | 2022-07-27
Health alert or recall Em2400 Exactamix Valve Set
Baxter is issuing an urgent medical device correction communication regarding the potential for leaking valves in the Exactamix 2400 valve sets. Baxter has observed an increase in complaints for leaking of ports 1 and 2 when in the closed position,…
RecallHealth product recall | 2022-07-25
Health alert or recall Dimension Vista System - Ca15-3 Flex Reagent Cartridge
Siemens Healthineers has received customer complaints for negative patient bias with the Dimension Vista Loci Ca15-3 assay. Siemens has confirmed the Dimension Vista Loci Ca15-3 lots show a negative bias with patient samples. The mean patient sample bias…
RecallHealth product recall | 2022-07-25
Health alert or recall Straight Rod - TI
On 03/17/2022, a Stryker spine operator packaging non-sterile Yukon Straight Rods from finished goods inventory discovered a Yukon Straight Rod 120 mm (cat#7601-540120, lot# pcmw) with orange and white discoloration on the surface of the device.…
RecallHealth product recall | 2022-07-20
Health alert or recall Centricity Radiology, Zero Footprint and Pacs Systems
GE Healthcare has become aware of two potential issues where inaccurate distance and area measurements can be displayed. Recall start date: May 5, 2022
RecallHealth product recall | 2022-07-15
Health alert or recall Anti-Lua (Lu1)
A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a…
RecallHealth product recall | 2022-07-11
Health alert or recall Pro+ Mattress
The Pro+ Mattress with Advanced Microclimate® Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned. The Pro+ hospital bed surface is a mattress…
RecallHealth product recall | 2022-07-11
Health alert or recall Aquac Uno H Reverse Osmosis System - Main Unit
On June 14, 2022, the manufacturer Fresenius Medical Care Ag & Co. Kgaa notified Fresenius Medical Care Canada, Inc. that during regular quality inspections of Aquac Uno H devices, it was discovered that the internal ethernet cable had not been…
RecallHealth product recall | 2022-06-27
Health alert or recall Fingertip Pulse Oximeter
Voluntary recall-interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Infrared Thermometer
Voluntary recall-interim order authorization not approved.  Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Digital Thermometer
Voluntary recall- interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Epoc Blood Analysis Bgem Test Cards
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. at a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-…
RecallHealth product recall | 2022-06-20
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