Philips Network Firewall Recall Due to Defective Clock Component
Philips is recalling 332 network firewalls used with IntelliVue systems due to a defective clock component that may cause loss of connection.
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 risk-of-harm product (medical device infrastructure) where the defect causes loss of communication and system reboots, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 332 units of the Philips Network Firewall (Cisco ASA 5506), Model # 867098. These devices were distributed nationwide in the United States and are used in conjunction with Philips IntelliVue Information Center iX or Information Center Classic systems.
The recall is due to a defective clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the component fails, the firewall will stop functioning, will not boot, and is not recoverable. This failure results in a loss of communication between devices separated by the firewall, which may cause the Information Center to reboot.
Affected serial numbers are listed in the official recall notice. Users should contact Philips Electronics North America Corporation for instructions on how to resolve the issue.
The recalled product
- Product
- Philips Network Firewall (Cisco ASA 5506), Model # 867098
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 332
Distribution
Distributed nationwide across the United States.
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