CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
NaviCare Patient Safety V3.9.200 to 3.9.600, used recalled
Baxter Healthcare is recalling NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed, distributed nationwide in the US. The recall was initiated on 19 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2007-2023
- FDA event ID
- 92300
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 May 2023
- FDA classified
- 26 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 19 May 2023 | Recall initiated by company | |
| 26 Jun 2023 | Classified by FDA | +38 days |
| 5 Jul 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Where it was distributed
US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
Nationwide ColoradoFloridaGeorgiaNorth CarolinaSouth CarolinaTennesseeVirginia
Questions about this recall
Why was it recalled?
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.
Which lots are affected?
UDI/DI 00887761985193, Software Versions: 3.9: 3.9.200,3.9.201, 3.9.300, 3.9.400, 3.9.401, 3.9.500, 3.9.600
Where was it sold?
US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92300| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Voalte Patient Safety recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
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