1/8/00 Class III recall
Software for Pulmonary Function Testing System:
a) BreezePF v3.8 Software, Catalog No. 147536-003;
b) BreezePF v3.8A Software, Catalog No. 147570-003.
An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1/FVC ratio is selected for diagnostic reporting. The problem only occurs when using the Quality Review or Bronchial Provocation Review software to select best composite efforts.
Medical Graphics Corporation, St. Paul, Minnesota.
Manufacturer, by bulletin on January 8, 2000. Firm-initiated field
Nationwide and international.
657 software disks were distributed.