Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 12, 2012
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighin
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be prop…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Respironics California Inc recalled V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 … - a critical-severity action.
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 … was recalled by Respironics California Inc in September 12, 2012. Reason: Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators ma…. Check the official notice for the remedy. Verify recall #Z-2260-2012 with the FDA Devices before acting.
The recall
Respironics California Inc issued this critical-severity FDA Devices recall-Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators ma….
- Critical
- severity level
- 197 units
- affected scope
- Class I
- classification
- September 12, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2260-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2260-2012) was formally reported on September 12, 2012, with the manufacturer initiating the action on July 31, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Respironics California Inc is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 197 units total (116 in the US).
The documented reason for this recall is: Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. … Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
197 units total (116 in the US)
Related Recalls
6
3 from same agency
Product description
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Reason for recall
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2260-2012 |
| Date reported | September 12, 2012 |
| Date initiated | July 31, 2012 |
| Recalling firm | Respironics California Inc |
| Firm location | Carlsbad, CA |
| Affected scope | 197 units total (116 in the US) |
| Distribution | Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom. |
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-2260-2012) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.. Recalled by Respironics California Inc. Units affected: 197 units total (116 in the US).
Why was this product recalled? ▼
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2012. Severity: Critical. Recall number: Z-2260-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2260-2012) 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 September 12, 2012. 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.