Recall Z-2007-2023 ยท FNL Bed, Ac-Powered Adjustable Hospital
Baxter Healthcare Corporation
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
| Date | Jun 26, 2023 (initiated May 19, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/19/2023 by letter (USPS). The notice explained the issue, hazard, and requested the following: Baxter is asking that you take the following actions: 1. Share this letter with your IT department (or other relevant personnel) to determine if you have the impacted software version and contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week, to schedule a software upgrade which addresses the identified issue. 2. You may continue to use your Voalte Patient Safety Soft |
| Quantity | 7 software versions |
| Distribution | US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.