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Displaying 1 - 15 of 16 items.

Health alert or recall Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube
Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend…
RecallHealth product recall | 2022-05-10
Health alert or recall Intelepacs
There is a possibility that a patient's final report sent out of Intelepacs contains the preliminary text instead of the final report text. This issue can manifest itself only: - In specific pacs-driven workflow configurations (e.g. multi-method…
RecallHealth product recall | 2022-05-03
Health alert or recall Xvivo Organ Chamber
It has come to Xvivo knowledge that the sterile barrier (welded polybag) show defects in the weld for a number of batches of the Xvivo Organ Chamber. Defect was categorized as unsealed sections of the weld (compromised sterile barrier). To reinforce the…
RecallHealth product recall | 2022-04-25
Health alert or recall Negative Pressure Wound Therapy Sved Device
Cardinal Health is initiating an urgent medical device correction to update the clinician and patient user manuals for the Negative Pressure Wound Therapy Sved Device to add pertinent information related to periodic preventative maintenance for this…
RecallHealth product recall | 2022-04-25
Health alert or recall Ellex Tango Reflex and Ultra Q Reflex devices
Posterior membranectomy as originally approved by Health Canada was with respect to 'dissection of pupillary membranes' and does not include vitreous membranes/ opacities.  Ellex Tango Reflex and Ultra Q Reflex devices were advised by Health Canada…
RecallHealth product recall | 2022-04-04
Health alert or recall Exalt Model D Single-Use Duodenoscope
Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to…
RecallHealth product recall | 2022-03-14
Health alert or recall Dabir
The device was incorrectly classified by manufacturer as a class I medical device and is in fact a class II medical device, which requires a medical device licence. Health Canada provided guidance on classification on December 24, 2021. Recall start…
RecallHealth product recall | 2022-03-14
Health alert or recall Spaceoar System
Boston Scientific received three reports of embolism that occurred outside of the pelvis. These events occurred as a result of inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis. As a…
RecallHealth product recall | 2022-03-07
Health alert or recall Temperature Probes
The esophageal/rectal/skin temperature probe's instructions for use, (IFU), contain inadequate instructions related to the cleaning and disinfection process for the reusable probes. The IFU instructs the user to clean the product with disinfecting agents…
RecallHealth product recall | 2022-02-21
Health alert or recall Magec 1
Post-implantation fracture of an internal metallic component (i.e., locking pin) had been observed in early version of Magec rods that were manufactured prior to March 26, 2015. In June 2019, Nuvasive Specialized Orthopedics issued a safety alert to…
RecallHealth product recall | 2022-02-14
Health alert or recall Heartware Ventricular Assist System
While performing a review of product literature, including the instructions for use (IFU) and patient manual (PM), It was identified that additional clarity was required around cleaning the power source connectors (controller AC adapter, DC adapter, and…
RecallHealth product recall | 2022-02-14
Health alert or recall Precice System
NSO is notifying that the products outlined are not indicated for use in individuals under the age of 18 years old. Also, NSO intends to make users aware of the gaps in the biological assessments for these devices as outlined in ISO 10993-1:2018…
RecallHealth product recall | 2022-01-10
Health alert or recall BIOGRAPH MCT
There is potential patient fall hazards could occur when the PHS pallet/foot extension is improperly assembled by the operator. PHS pallet/foot extension patient fall hazards could occur when the extension is improperly used to position…
RecallHealth product recall | 2021-11-26
Health alert or recall BIOGRAPH LSO 16 SLICE PET
There is potential patient fall hazards could occur when the PHS pallet/foot extension is improperly assembled by the operator. PHS pallet/foot extension patient fall hazards could occur when the extension is improperly used to position…
RecallHealth product recall | 2021-11-26
Health alert or recall Miami J Select Cervical Collar
The instructions for use require additional information to facilitate the selection and use of the device. Recall start date: 2021-11-01  
RecallHealth product recall | 2021-11-12
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