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

FDA device recall Z-1469-2008 · posted 2008-08-13 · Terminated

Recall details

Recalling firm

Cardinal Health 203, Inc

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.

Action taken

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

Status

Terminated

Product code

CBK

Quantity affected

2,503 ( 1,128 US, 1,375 OUS)

Distribution

Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finlan

Date initiated

2008-02-22

Date posted

2008-08-13

Date terminated

2012-08-16

Location

Minneapolis, MN

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