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Terminated

Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics

FDA Recall Z-0903-04 · Posted 2004-07-20

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2001-06-01
Date Terminated2004-05-12
Product Quantity749

Reason for Recall

Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.

Firm Action

Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.

Root Cause

Other

Distribution Pattern

Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981072ESPRIT 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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