RecallDepth

Power Board Kit for use with the PLV-100 Portable Lifecare repairs

Company
Respironics, Inc.
Recall Initiated
July 8, 2008
Posted
September 18, 2008
Terminated
April 23, 2009
Recall Number
Z-2345-2008
Quantity
197
Firm Location
Murrysville, PA

Reason for Recall

Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.

Distribution

Worldwide Distribution ---USA: NC, IL, NJ, MO, TX , OH, IA, and OK and countries of Japan, Denmark, Korea, Australia, Finland, Canada, Argentina, New Zealand, Hong Kong, and India.

Lot / Code Info

Model/Catalog number PLV-100. Circuit board part numbers 1034786 version 5 or 1036038 version 3

Root Cause

Finished device change control

Action Taken

The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/8/08. The letter informed the customer of the problem and the need to contact the firm for a replacement. Contact Respironics Customer Service at 1-877-387-331 for assistance.

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