Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 5, 2023
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
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 ma…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corporation recalled Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed - a moderate-severity action.
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed was recalled by Baxter Healthcare Corporation in July 5, 2023. Reason: Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter…. Check the official notice for the remedy. Verify recall #Z-2006-2023 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this moderate-severity FDA Devices recall-Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter….
- Moderate
- severity level
- Class II
- classification
- July 5, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2006-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2006-2023) was formally reported on July 5, 2023, with the manufacturer initiating the action on May 19, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 8 software versions.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8 software versions
Related Recalls
6
3 from same agency
Product description
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2006-2023 |
| Date reported | July 5, 2023 |
| Date initiated | May 19, 2023 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 8 software versions |
| Distribution | US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2006-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed. Recalled by Baxter Healthcare Corporation. Units affected: 8 software versions.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-2006-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2006-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 5, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.