Day

January 15, 2014
Company: Welch Allyn Protocol, Inc Date of Enforcement Report:1/15/2014 Class lI: PRODUCT The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate...
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Company: Covidien. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions...
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Lisa Simone, a biomedical software engineer at FDA, published an article in the Biomedical Instrumentation & Technology Journal (Nov-Dec 2013) with information on an analysis of historical software related recalls using internal information at FDA as well as other sources. The article breaks down the recalls by year and product type. She investigated the years...
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Company: EOS Imaging Date of Enforcement Report:1/15/2014 Class lI: PRODUCT EOS System X- ray beam Digital radiography system used in general radiographic examinations. Recall Number Z-0529-2014 REASON EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from...
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Company: Carestream Health Inc. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Carestream DRX-Revolution Mobile X-Ray System — Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 — The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products...
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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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