Arial Server Software Fails to Notify Users of Emergency Calls
Securitas Healthcare's Arial Server Software versions 11.1.4 through 11.1.6 may fail to notify users when emergency calls are initiated through the Arial Nurse Call System, posing a patient safety risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II FDA medical device recall of a nurse call system notification software. Matches the score 3 criterion: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Securitas Healthcare LLC has recalled Arial Server Software versions 11.1.4 through 11.1.6 (SKU 54305), used in conjunction with the Arial Mobile Application or Arial Care Giver Application as part of the Arial Emergency and Nurse Call System. The recall affects 111 systems distributed worldwide, including the United States, Canada, and Switzerland.
The affected software versions fail to notify end users when emergency calls are initiated by call points. This notification failure could result in delayed response to time-sensitive patient emergencies.
Healthcare facilities using the affected software should contact Securitas Healthcare LLC for information about corrective measures.
The recalled product
- Product
- Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
- Manufacturer
- Securitas Healthcare LLC
- Affected units
- 111
Distribution
Distributed nationwide across the United States.
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