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Voalte Patient Safety, Part Number 4.0, V4.0.000 to… recallZ-2006-2023 · Baxter Healthcare Corporation · initiated May 19, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

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 Software (VPS) (with your Centrella bed) until a software upgrade is completed by implementing either of these options into your clinical bedside workflow: Option 1: When working with a patient in the room, and a bed exit alarm is activated, only silence the bed, and extend the silence timer instead of turning off bed exit. " At the Graphical Room Station (GRS), click Menu " Click Manage Bed " On the Manage Bed screen, click the Safety Alerts ON / OFF slider button and the Delay button will pop up. Extend the silence period for the desired amount of time. Option 2: After working with a patient in the room, and prior to exiting the room, enable Patient Safety at the Graphical Room Station (GRS). " At the Graphical Room Station, click Menu " Click Manage Bed on the Manage Bed screen, toggle the Safety Alerts button to ON . For general questions regarding this communication, contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week.

Recall details

Recall number
Z-2006-2023
Status
Open, Classified
Initiated by the company
May 19, 2023
Posted by the FDA
Jun 26, 2023
Recalling firm
Baxter Healthcare Corporation
Quantity
8 software versions
Product code
FNL
Distribution
US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.

Product description

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

Code information (models, lots, serial numbers)

UDI/DI 00887761995086, Software Versions: 4.0: 4.0.000, 4.0.100, 4.0.110, 4.0.200, 4.0.300, 4.0.301, 4.0.400, 4.0.401

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92300).

Sources and updates

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