Ventilator

Catalog numbers: 8416400/8417400 distributed June 2011  October 2015.

Anesthesiology Devices

2

No

US Nationwide-including DC and PR, and the states of AK; AR; AZ; CA; CO; CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD; TN; TX; UT; VA; VT; WA; WI; and WV.

Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. || Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.

All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.

Anesthesiology Devices

2

No

Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Emergency Transport Ventilator || Oxylog 2000 Plus Ventilator || Catalog Number: 5705080. || Volume controlled emergency and transport ventilator with pressure support.

All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.

Anesthesiology Devices

2

No

Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Emergency Transport Ventilator || Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator || Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. || Volume controlled and pressure-controlled emergency and transport ventilators.

all versions of software.

Anesthesiology Devices

2

No

Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.

Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). || Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.

11 digit S/N begginning with GV or TV; also TGY1D01463

Anesthesiology Devices

2

No

Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.

Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, || Trilogy EC, Garbin, Garbin Plus || Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.