Pulmonetic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What Pulmonetic Systems, Inc. makes
Pulmonetic Systems, Inc. manufactures mechanical ventilators, including portable and transportable models such as the LTV 1000, LTV 1200, and PalmTop ventilators (PTV-8, PTV-10). Their product line also includes modifications for existing ventilators and accessories like power cords for vehicle use. These devices are designed for respiratory support in clinical and emergency settings.
The company’s ventilators are classified as Class II medical devices under FDA regulations and are recorded in the 510(k) clearance registry. Their products are listed in the United States, where they comply with applicable FDA requirements for ventilators and related modifications.
Catalogue
Search and filter all 12 devicesFDA recalls
FDA recall records list 7 recalls initiated by Pulmonetic Systems, Inc., the earliest on 2004-11-19 and the most recent on 2005-11-09. By recorded status: 7 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 9 Nov 2005 Z-0184-06 Unclassified (pre-2012) Terminated Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
Full distribution text
- 9 Nov 2005 Z-0185-06 Unclassified (pre-2012) Terminated Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
Full distribution text
- 9 Nov 2005 Z-0186-06 Unclassified (pre-2012) Terminated Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
Full distribution text
- 9 Nov 2005 Z-0184-06 Unclassified (pre-2012) Terminated Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
2004
- 19 Nov 2004 Z-0274-05 Unclassified (pre-2012) Terminated Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
- 19 Nov 2004 Z-0294-05 Unclassified (pre-2012) Terminated Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
- 19 Nov 2004 Z-0295-05 Unclassified (pre-2012) Terminated Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
- 19 Nov 2004 Z-0296-05 Unclassified (pre-2012) Terminated Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
Frequently asked questions
How many devices does Pulmonetic Systems, Inc. have in the registry?
The registry currently lists 12 devices for Pulmonetic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pulmonetic Systems, Inc.'s devices?
Among its 12 most recently registered devices, Pulmonetic Systems, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Pulmonetic Systems, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Pulmonetic Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pulmonetic Systems, Inc.?
FDA recall records list 7 recalls initiated by Pulmonetic Systems, Inc., the most recent initiated on 9 Nov 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Pulmonetic Systems, Inc. in the registry?
The most recently registered devices listed for Pulmonetic Systems, Inc. include LTV 1000 VENTILATOR, PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR, MODIFICATION TO LAP TOP VENTILATOR (LTV) and PALMTOP VENTILATOR, MODELS PTV-8, PTV-10.