Product Wiki · Recalls · Health Canada — Medical Devices

Essenta Dr Compact Digital Radiography System — recall 74215

Health Canada — Medical Devices · Canada · 2023-08-30 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74215
Date of alert
2023-08-30
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Radiology
Product type
Medical devices
Reported risk: There is a potential cybersecurity issue with Essenta Dr Compact Systems, which could result in unauthorized disclosure or modification of patient data. This issue may occur if a firewall is not in place, the file transfer protocol (ftp) is utilized, and the following sequence of events occurs: • unauthorized personnel gains physical access to customer facility • customer facility does not have a firewall and/or network segregation to isolate medical devices, and • the unauthorized person connects their device to the Essenta Dr Compact System network at the specific time data is transferred (data is not continuously transferred). Under these conditions unauthorized access or modification of patient data is possible. Recall start date: August 18 , 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/essenta-dr-compact-digital-rad

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.