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Terminated

Esprit Ventilator

FDA Recall Z-1230-04 · Posted 2004-07-28

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2002-02-20
Date Terminated2004-12-02
Product Quantity907

Reason for Recall

Flow sensors would exhibit drift.

Firm Action

Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thailand, Turkey, Taiwan, Venezuela Vietnam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K034040ESPRIT VENTILATOR, MODEL V1000Respironics, Inc. · 2004-01-21K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICSRespironics California, Inc. · 2002-11-06K001208ESPIRTRespironics, Inc. · 2000-05-12K981072ESPRIT VENTILATORRespironics, Inc. · 1998-11-12

Official Source

View FDA Recall →

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

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