02
Oct
2002

Inc Class II Medical Data Electronics

0

Company: Medical Data Electronics, Inc
Date of Enforcement Report: 10/02/02
Class: II

PRODUCT
Defibrillator/ Pacer
Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202. Recall # Z-1360-2.

REASON
Intermittent operation of the paddles.

CODE
Serial Numbers 10392 thru 10540.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Medical Data Electronics, Inc., Arleta, CA, by letter on August 1, 2002.
Manufacturer: Medical Research Laboratories, Arleta, CA. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
54 sets of two paddles each.

DISTRIBUTION
Nationwide and Pakistan and Mexico.

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.

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