1/8/00 Class III recall
PRODUCT
Software for Pulmonary Function Testing System:
a) BreezePF v3.8 Software, Catalog No. 147536-003;
b) BreezePF v3.8A Software, Catalog No. 147570-003.
Recall #Z-450/451-0.
REASON
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.
CODE
None.
MANUFACTURER
Medical Graphics Corporation, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by bulletin on January 8, 2000. Firm-initiated field
correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
657 software disks were distributed.
