Stanley Healthcare Recalls Arial 54315 Network Manager Due to Outages
Stanley Healthcare is recalling 137 Arial 54315 Network Managers because they caused outages in the Arial nurse call system.
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: The recall involves a medical device (nurse call system) where outages pose a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stanley Healthcare is recalling 137 units of the Arial 54315 Network Manager, also known as the Serial-to-IP Network Gateway. The recall was initiated after the company received reports of outages on the Arial nurse call system. These outages were traced back to the recalled network gateway units.
The affected units were distributed nationwide in the United States and in Canada. The recall covers specific serial numbers listed in the official FDA record. No specific dates of distribution or installation are provided in the source text.
Healthcare facilities using the Arial nurse call system should check their inventory for the affected serial numbers. Stanley Healthcare is the recalling firm responsible for addressing the issue.
The recalled product
- Product
- STANLEY Healthcare Arial 54315 Network Manager
- Manufacturer
- Stanley Security Solutions Inc
- Hazard
- Affected units
- 137
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 0008DC517FD2
- 0008DC517FD3
- 0008DC517FD4
- 0008DC517FD5
- 0008DC517FD6
- 0008DC517FD7
- 0008DC517FD8
- 0008DC517FD9
- 0008DC517FDA
- 0008DC517FDB
- 0008DC517FDC
- 0008DC517FDD
- 0008DC517FDE
- 0008DC517FDF
- 0008DC517FE0
- 0008DC517FE1
- 0008DC517FE2
- 0008DC517FE3
- 0008DC517FE4
- 0008DC517FE5
Distribution
Distributed nationwide across the United States.
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