Cardinal Health 203, Inc: Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447.

Recall number

Z-1466-2008

Recalling firm

Cardinal Health 203, Inc

Product

Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447.

Status

Terminated

Initiated

2008-02-22

Posted

2008-08-13

Terminated

2012-08-16

Reason

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.

Root cause

Device Design

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.

Quantity

337 ( 328 US, 9 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, 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.

Lot, serial or model codes

Serial numbers: D01002, D01004, D01005, D01006, D01007, D01011, D01013, D01014, D01015, D01016, D01017, D01018, D01019, D01024, D01025, D01026, D01027, D01031, D01033, D01034, D01035, D01037, D01038, D01040, D01043, D01044, D01045, D01046, D01048, D01049, D01051, D01053, D01055, D01056, D01060, D01066, D01067, D01068, D01069, D01070, D01071, D01072, D01074, D01075, D01076, D01078, D01079, D01080, D01083, D01084, D01086, D01087, D01091, D01092, D01094, D01096, D01097, D01098, D01099, D01100, D01103, D01104, D01106, D01107, D01108, D01111, D01113, D01114, D01118, D01121, D01122, D01124, D01125, D01126, D01127, D01130, D01131, D01133, D01136, D01137, D01138, D01139, D01140, D01142, D01144, D01145, D01147, D01149, D01152, D01153, D01154, D01157, D01162, D01165, D01166, D01168, D01169, D01170, D01172, D01173, D01174, D01175, D01176, D01177, D01179, D01181, D01183, D01185, D01186, D01187, D01189, D01190, D01191, D01192, D01193, D01194, D01195, D01196, D01197, D01198, D01199, D01300, D01301, D01302, D01303, D01304, D01306, D01307, D01308, D01309, D01310, D01311, D01312, D01313, D01316, D01317, D01318, D01319, D01320, D01321, D01324, D01325, D01326, D01329, D01330, D01332, D01335, D01336, D01400, D01401, D01402, D01403, D01404, D01405, D01406, D01407, D01408, D01409, D01410, D01411, D01412, D01413, D01414, D01415, D01417, D01418, D01419, D01420, D01421, D01423, D01424, D01425, D01426, D01427, D01428, D01430, D01432, D01434, D01435, D01436, D01437, D01438, D01439, D01440, D01441, D01442, D01443, D01444, D01445, D01446, D01447, D01448, D01449, D01450, D01451, D01452, D01453, D01454, D01455, D01456, D01457, D01458, D01460, D01461, D01462, D01464, D01465, D01466, D01467, D01468, D01470, D01471, D01472, D01473, D01474, D01475, D01476, D01477, D01478, D01479, D01480, D01481, D01482, D01483, D01484, D01485, D01486, D01487, D01488, D01489, D01490, D01491, D01492, D01493, D01494, D01495, D01496, D01497, D01499, D01500, D01501, D01502, D01505, D01506, D01507, D01508, D01509, D01510, D01511, D01512, D01513, D01514, D01515, D01516, D01517, D01518, D01519, D01520, D01521, D01522, D01523, D01524, D01525, D01526, D01527, D01528, D01529, D01530, D01531, D01532, D01533, D01534, D01535, D01536, D01537, D01538, D01539, D01540, D01541, D01542, D01543, D01544, D01545, D01546, D01547, D01548, D01549, D01550, D01551, D01552, D01553, D01554, D01555, D01556, D01557, D01558, D01559, D01560, D01561, D01562, D01563, D01564, D01565, D01566, D01567, D01568, D01569, D01570, D01571, D01572, D01573, D01574, D01575, D01576, D01577, D01578, D01579, D01580, D01581, D01582, D01583, D01584, D01585, D01586, D01587, D01588, D01589, D01590, D01591, D01592, D01593, D01594, D01595, D01596, D01597, D01598, D01599

510(k) numbers

["K002881","K010508","K040540","K981371","K984056"]

PMA numbers

not on file

Product code

CBK

Firm FEI

3002617992

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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