Pulmonetic Systems, Inc.

B01117, B01236, B01483, B01637, B01640, B01655, B01802, B01816, B01954, B01974, B01997, B03500-B03524, B03526-B03536

Anesthesiology Devices

2

No

Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom

Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional, home and transport settings.

C01063, C01112, C01605, C02231, C02247, C02488, C03055, C03096, C03123, C03137, C03437, C03492, C03828, C03861, C03884, C04056, C04580, C05336, C06640, C07105-C07107, C07109-C07113, C07115, C07116, C07118, C07122-C07126, C07130, C07141, C07145, C07152, C07154, C07157-C07160, C07162, C07168, C07170, C07173, C07188, C07194 and C07195

Anesthesiology Devices

2

No

Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom

Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings.

A01916, A01961, A02196, A02656, A02985, A03667, A03696, A03741, A03774, A03809, A04262, A05454, A06194, A06585-A06598, A06600-A06613, A06615, A06616, A06618-A06620, A06622-A06624, A06626-A06630, A06633, A06635-A06637, A06639-A06654, A06656-A06659, A06661-A06670, A06672-A06684, A06686-A06696, A06698-A06700, A06702-A06707, A06709, A06710, A06712-A06716, A06734, A06746-A06748, A06750, A06755-A06758, A06760-A06763, A06765-A06766, A06769, A06771, A06779-A06780, A06783-A06785 and A07226.

Anesthesiology Devices

2

No

Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom

Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings.

all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.

Anesthesiology Devices

2

No

throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan

Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 1000 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)

all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.

Anesthesiology Devices

2

No

throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan

Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 900 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)