Philips Patient Information Center iX UPS devices recalled for potential power failure
Philips is recalling certain Patient Information Center iX Uninterruptable Power Supply devices due to potential power supply failures that could cause the monitoring system to shut down, risking delays in detecting patient condition changes.
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: This is an FDA Class II medical device recall involving potential system failure that could delay patient condition detection. No deaths, injuries, or hospitalizations have been reported. The hazard is theoretical, qualifying this as High severity under the rubric criteria for risk-of-harm products without reported illness.
Plain-English summary
Philips North America LLC is recalling certain Uninterruptable Power Supply (UPS) devices used in Philips Patient Information Center (PIC) iX systems. The recalled devices are APC 120V model SCL500RM1U with serial number date codes prior to 2237, and APC 230V model SCL500RMI1U with serial number date codes prior to 2241, manufactured by Schneider Electric IT Corporation. Approximately 12,936 units have been distributed worldwide.
The UPS devices may fail, causing the associated PIC iX system to lose power and shut down. This failure could delay the detection of changes in a patient's condition, potentially compromising patient monitoring and care.
Healthcare facilities using these devices should identify affected units by checking serial numbers and contact Philips for instructions on repair or replacement. Device operators should verify backup power protection and maintain alternate monitoring procedures as appropriate.
The recalled product
- Product
- Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model…
- Manufacturer
- Philips North America Llc
- Affected units
- 12,936
Distribution
Distributed nationwide across the United States.
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