Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mec
FDA device recall Z-0808-06 · posted 2006-05-02 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- Reason for recall
- Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit to ambient air. Ventilator dependent patients may not receive adequate ventilatory support if this problem occurs.
- Action taken
- Notification letters were mailed to customers on March 20, 2006 notifying them of this action. Customers were instructed to quarantine all PLV Continuum Ventilators in their possession and not to place patients on them. Respironics Customers Service will contact customers to arrange for the return of all PLV Continuum Ventilators. Customers were instructed to safely plan and transition patients in their care from the PLV Continum Ventilator onto to other comparable patient support devices. If customers did not have a suitable ventilator to use for their patients, Respironics will loan them a PLV 100, 102 or 102b Ventilator with no charge. If patient support goes beyond the capabilities of the PLV 100, 102, or 102b Ventilator is required, Respironics will make arrangements to loan the customer with a suitable substitute rental ventilator at no charge. The field action will involve the upgrade of all affected devices with a new flow valve assembly. All US and International units are being recalled to the factory in Carlsbad, California. The rework will be conducted on-site.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- Domestic (235) + International Distribution (42)=277 units
- Distribution
- Nationwide, plus Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia, & Taiwan
- Date initiated
- 2006-03-20
- Date posted
- 2006-05-02
- Date terminated
- 2008-04-21
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLV CONTINUUM VENTILATOR, MODEL P1000 (K022750) | Respironics California, Inc. | 2003-11-20 |