Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported August 1, 2018
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Human Design Medical Llc recalled Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide c… - a low-severity action.
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide c… was recalled by Human Design Medical Llc in August 1, 2018. Reason: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.. Check the official notice for the remedy. Verify recall #Z-2530-2018 with the FDA Devices before acting.
The recall
Human Design Medical Llc issued this low-severity FDA Devices recall-Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool..
- Low
- severity level
- 45 units
- affected scope
- Class III
- classification
- August 1, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2530-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2530-2018) was formally reported on August 1, 2018, with the manufacturer initiating the action on May 8, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Human Design Medical Llc is listed as the recalling firm, operating out of Boston, MA. Federal records list the affected scope as 45.
The documented reason for this recall is: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.. 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 - 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 - 40,422 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
45
Related Recalls
6
0 from same agency
Product description
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Reason for recall
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2530-2018 |
| Date reported | August 1, 2018 |
| Date initiated | May 8, 2018 |
| Recalling firm | Human Design Medical Llc |
| Firm location | Boston, MA |
| Affected scope | 45 |
| Distribution | US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX. |
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-2530-2018) 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? ▼
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Recalled by Human Design Medical Llc. Units affected: 45.
Why was this product recalled? ▼
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Low. Recall number: Z-2530-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2530-2018) 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.
Nearby Recalls in This Category
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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 August 1, 2018. 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.