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.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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