REASON
The software validation of version 4.01R1 a software anomaly was found
that affected the proper function of a print option.
PRODUCT
Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG
software feature used in conjunction with the Critikon Observer Central
Station on which is installed. There are 12 models or catalog numbers of
the software option involved as follows:
88951-8 Patient Arrhythmia, S-T, 24 hour Disclosure Software (Hardwire)
88961-8 Patient Arrhythmia, S-T, 1 hour Disclosure Software (Hardwire)
88971-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (Hardwire)
88991-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (Hardwire)
88911-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900MHz)
88921-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz)
88931-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900 MHz)
88941-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz)
88821-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF)
88831-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF)
88841-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF)
88851-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF).
Recall #Z-383/394-0.
CODE
The only reference numbers are the Catalog Numbers listed above.
MANUFACTURER
Vital Com, Tustin, California (software).
RECALLED BY
Critikon Company LLC, Tampa, Florida (distributor), by telephone on
October 27, 1999. Firm-initiated field correction (software retrofit)
complete.
DISTRIBUTION
Tennessee, Texas, Missouri, Georgia, Wisconsin, Illinois,
South Carolina, Ohio, Alabama, Egypt.
QUANTITY
There are 15 OBSEVER Central Stations with the VitalCom ST Segment
Arrhythmia Detection Software Option installed in commerce.
