🏥 Medical Devices • 4,350 recalls
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Medtronic Neuromodulation
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
American Contract Systems
Sterility assurance with procedure trays
The RSV target may give a late Ct value and could potentially not pass QC.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
American Contract Systems
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
American Contract Systems
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
American Contract Systems
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
American Contract Systems
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).