Medical Data Electronics Patient Monitor Class II

PRODUCT

Escort E300 Series Patient Monitor, intended use is as an
electrocardiograph and respiration monitor.

Recall #Z-030-1.

REASON

It is possible for the High Breath Rate Alarm to function incorrectly
under certain conditions.

CODE

Serial numbers are non-sequential (there are gaps), are four digits long
and include: 1001 to 4086.

MANUFACTURER

Medical Data Electronics, Arleta, Georgia.

RECALLED BY

Manufacturer, by letter dated July 7, 2000. Firm-initiated recall
ongoing.

DISTRIBUTION

Nationwide, Belgium, Canada, Czech Republic, England, Finland, France,
Greece, Hong Kong, India, Italy, Korea, Kuwait, Netherlands, Norway,
Russia, South Africa, Sweden, Switzerland, Taiwan, ROC, Turkey, United
Arab Emirates, United Kingdom.

QUANTITY

483 units were distributed.

CODE

All units, all software versions.

MANUFACTURER

Abbott Laboratories, Inc., Irving, Texas.

RECALLED BY

Abbott Laboratories, Inc., Abbott Park, Illinois, by letter on April 25,
2000. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide, Puerto Rico, Korea, Mexico, Canada, Germany, Japan,
Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Australia, New Zealand.

QUANTITY

603 units 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.

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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