NaviCare Nurse Call System Cancels Patient Calls During Wireless Use
The NaviCare Nurse Call system software (versions 3.9.100-3.9.300) has a wireless integration defect causing patient calls to be canceled when answered on wireless phones. The issue affects 283 installations in the US and Canada.
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 with a system malfunction that creates risk of patient harm in healthcare settings. No illnesses or injuries reported to date. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Baxter Healthcare Corporation has recalled the NaviCare Nurse Call/Voalte Nurse Call system software (versions 3.9.100 through 3.9.300). The software is used with wireless integrations from Phillips (Emergin), Longleaf, Connexall, Vocera, and Cerner systems.
The defect causes calls placed from push-button call devices—including call cords and room audio station buttons—to be canceled when a nurse answers on a wireless phone. This occurs regardless of call priority, preventing proper nurse-patient communication.
Approximately 283 installations of this software are in use nationwide and in Canada. Healthcare facilities using the affected software versions should contact Baxter Healthcare Corporation for information about software updates or remediation options.
The recalled product
- Product
- NaviCare Nurse Call/Voalte Nurse Call
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 283
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 (6)
- software versions: 3.9.100
- 3.9.101
- 3.9.102
- 3.9.200
- 3.9.201
- and 3.9.300
Distribution
Distributed nationwide across the United States.
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