Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Gray Sheet

Executive Summary

EDENTEC REPLACES DEFECTIVE CAPACITORS IN ADULT/INFANT APNEA MONITORS as part of a recent Class I recall. The recall involved 378 Model 2000W and Model 2000W Option H heart/respiration monitors and five System 700 monitors, which incorporate a recording device. EdenTec says it has contacted all consignees and has replaced capacitors in an unspecified number of "recoverable" devices; the remaining devices are "unrecoverable," according to the firm. The products were distributed domestically and in Germany. The monitors were recalled because they potentially "fail to alarm (both visually and audibly) during an apnea event," according to the FDA's March 31 Enforcement Report (see box below). EdenTec, which was alerted to the problem by a user, says that there have been no reports of serious injury or death associated with the devices. On Jan. 20 and Feb. 8, EdenTec sent letters to customers informing them of the potential problem and asking them to return the device for replacement of the defective capacitor. The firm suspects that one lot of components from its supplier were defective. The same monitor models were recalled for a different reason in mid-1992. In that recall, which was also deemed a Class I action by FDA, the firm repaired malfunctioning printed circuit boards ("The Gray Sheet" July 13, 1992, p. 18). EdenTec says the two recalls are unrelated.

You may also be interested in...

US FDA Pharmaceutical Quality Office Lauds Continuous Manufacturing Approvals

The FDA’s OPQ touts approval of sixth and seventh continuously manufactured drugs and quicker delivery of inspection results in latest annual report.

Warning Letter Roundup & Recap – 19 February 2020

No device-related warning letters were released by the US FDA the week of 19 February.

Harmonization Needed For Complex And Value-Added Drugs

Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts