FDA Devices recall · Reported October 29, 2014
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery i…
Respironics California Inc recalled Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power… - a critical-severity action.
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power… was recalled by Respironics California Inc in October 29, 2014. Reason: A failure of a specific component may prevent the ventilators from operating on AC power or transitioning bac…. Check the official notice for the remedy. Verify recall #Z-0008-2015 with the FDA Devices before acting.
The recall
Respironics California Inc issued this critical-severity FDA Devices recall-A failure of a specific component may prevent the ventilators from operating on AC power or transitioning bac….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- October 29, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0008-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Reason for recall
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0008-2015 |
| Date reported | October 29, 2014 |
| Date initiated | September 17, 2014 |
| Recalling firm | Respironics California Inc |
| Firm location | Carlsbad, CA |
| Affected scope | 2,206 units total (665 units in US) |
| Distribution | Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philipp… |
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-0008-2015) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026