Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide cont
FDA device recall Z-0185-06 · posted 2005-11-23 · Terminated
Recall details
- Recalling firm
- Pulmonetic Systems, Inc.
- Reason for recall
- 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.
- Action taken
- Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 51
- Distribution
- 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
- Date initiated
- 2005-11-09
- Date posted
- 2005-11-23
- Date terminated
- 2007-01-04
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO LAP TOP VENTILATOR (LTV) (K010608) | Pulmonetic Systems, Inc. | 2001-03-20 |
| VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 (K002881) | Pulmonetic Systems, Inc. | 2000-10-11 |
| LTV 1000 (K984056) | Pulmonetic Systems, Inc. | 1999-04-12 |
| LTV 1000 VENTILATOR (K981371) | Pulmonetic Systems, Inc. | 1998-10-30 |