Nurse Call System Recall Due to Firmware Memory Leak
Baxter Healthcare is recalling 1,414 Voalte Nurse Call System units distributed to North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
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: FDA Class II medical device recall affecting a critical healthcare communication system. Although no illnesses or injuries have been reported, the product represents a risk-of-harm category (hospital patient-staff communication) without documented harm, warranting a High severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling 1,414 units of the Voalte Nurse Call System due to a firmware memory leak discovered in a supplier-manufactured component. The affected model is P2519NNC3A24 (UDI: 00887761995079).
The Voalte Nurse Call System provides comprehensive communication and information management for healthcare facilities, enabling patient calls, staff calls, and emergency alerts. A firmware memory leak in a supplier-manufactured component was identified as the reason for this recall.
The recalled units were distributed to healthcare facilities in North Carolina and Virginia.
The recalled product
- Product
- Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 1,414
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 (3)
- Internal Part Number: 4.0.
- UDI/GTIN: 00887761995079
- P2519NNC3A24 model number of impacted RubyTech Switch
Distribution
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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