Retiro De Equipo (Recall) de Device Recall AirLife nCPAP System Driver

Recall

38062

Class 2

Z-1075-2007

2007-06-01

2007-07-12

Terminated

United States

2007-12-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52879

Under isolated conditions, the device may experience issues with o2 calibration, which may result in either a nuisance alarm or a delivered fio2 of up to 5% below the specified tolerance.

Cardinal Health sent the accounts recall letters dated 6/1/07 via UPS next day delivery, which listed the catalog number and affected serial numbers of the CPAP Driver, and informed them that under certain isolated conditions, the CPAP Driver may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance. Customers have experienced this under the following conditions: 1) air inlet pressure is greater than O2 pressure by 5 to 10 psi and 2) FiO2 settings less than 45%. Separate recall letters were sent to those accounts who had filed complaints of O2 Calibration Errors, stating that their device will be replaced by the end of June, 2007; those accounts who purchased the devices, but had not reported O2 Calibration Errors, stating that a Cardinal Health representative will upgrade the firmware on the devices at their facility by the end of August, 2007; and those accounts who had had demonstration units in their possession, advising them to notify their sales representative if any of the conditions mentioned in the letter occurred. The accounts were requested to complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of affected drivers in their possession, and were advised that they would be contacted by a Cardinal Health representative to arrange for the replacement/service of their drivers. Any questions were directed to Quality Systems-Professional Services at 1-800-292-9332 or 1-800-327-7503.