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.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.