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.
What this means for you
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
- firmware-memory-leak
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
Distributed in 2 states:
- NC
- VA
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