NaviCare Nurse Call System: Firmware Memory Leak in Supplier Component
Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in 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 of a critical hospital communication system due to a firmware defect. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 11,028 units of the NaviCare Nurse Call System due to a firmware memory leak discovered in a supplier-manufactured component. The affected systems were distributed to healthcare facilities in North Carolina and Virginia.
The NaviCare Nurse Call System provides communication and information functionality for patient calls, staff calls, and emergency calls in healthcare settings. The firmware defect affects systems with the internal part number 3.9 component (RubyTech Switch model P2519NNC3A24, UDI 00887761985209).
Healthcare facilities with affected NaviCare systems should contact Baxter Healthcare Corporation for information about remediation options for this firmware defect.
The recalled product
- Product
- NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 11,028
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: 3.9.
- UDI/GTIN: 00887761985209
- 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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