Vitalcom Arrhthmis Detection Software Class II

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.

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3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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