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Terminated

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

FDA Recall Z-2345-2008 · Posted 2008-09-18

Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2008-07-08
Date Terminated2009-04-23
Product Quantity197

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.

Firm Action

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.

Root Cause

Finished device change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K832467PORTABLE LIFECARE VENTILATOR PLV-100Lifecare Services, Inc. · 1983-10-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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