Medical Graphics Corp Pulmonary Test SW

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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