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Terminated

Replacement Kit, Power PCBA with Memory PCBA. REF 14425. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.

FDA Recall Z-1469-2008 · Posted 2008-08-13

Recalling FirmCardinal Health 203, Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2008-02-22
Date Terminated2012-08-16
Product Quantity2,503 ( 1,128 US, 1,375 OUS)

Reason for Recall

The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.

Firm Action

An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040540MODIFICATION TO LTV 1000 VENTILATORPulmonetic Systems, Inc. · 2004-04-29K010508PASCO MIC AND MIC/ID PANELSPasco Laboratories, Inc. · 2001-04-23K002881VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000Pulmonetic Systems, Inc. · 2000-10-11K984056LTV 1000Pulmonetic Systems, Inc. · 1999-04-12K981371LTV 1000 VENTILATORPulmonetic Systems, Inc. · 1998-10-30

Official Source

View FDA Recall →

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

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