Stationary Radiographic System Recall Continues
The FDA Enforcement Report for the week of March 13, 2013, lists the ongoing recall of the Philips digital Diagnost stationary radiographic system. Recalled on October 30, 2012 by Philips Healthcare...
View ArticleIdentity Issues Prompt Recall
The Enforcement Report for the week of March 20, 2013 lists the continuing recall of the Elekta Synergy XVI, a radiation therapy digital imager. The Class II Recall includes the XVI R3.5.1, R4.2.1, and...
View ArticleClass I Recall of Anesthesia Workstations and Service Kits
The FDA advises biomedical engineering, anesthesiology, and risk managers of the Class I Recall Spacelabs anesthesia workstations and service kits due to a defect in CAS I/II absorbers. The defect in...
View ArticleSmiths Medical Recalls BCI Remote Alarm Cables
As reported in a recent FDA MedWatch news release, Smiths Medical (St Paul, Minn) has issued a recall for its BCI Remote Alarm Cables. The cables are designed for use with the 9004 Capnocheck...
View ArticleClass I Recall for Respironics Ventilators
First initiated on June 4, 2013, the manufacturer’s recall of approximately 19,200 Philips Respironics V60 ventilators has been given the Class I designation by FDA. That designation indicates that...
View ArticlePuritan Bennet Ventilator Recalled
On January 10, the FDA announced on its website that it had notified healthcare professionals that Covidien’s Puritan Bennett 840 Series Ventilator has been recalled due to a software problem. The...
View ArticleDräger Recalls Ventilator Power Supply
On April 2, the FDA announced that respiratory equipment manufacturer Dräger Medical, Telford, Pa, has issued a recall of its optional PS500 power supply unit used with the Evita V500 and Babylog VN500...
View ArticleCareFusion Ventilators Recalled
On October 10, the FDA announced a Class 1 recall of CareFusion’s EnVE and ReVEL ventilators, related to possible power connection failure. According to the agency, “there is a potential for damage to...
View ArticleSoftware Bug Leads to Recall of Puritan Bennett Ventilators
The FDA announced on November 7 that it has notified healthcare facilities of the Class 1 recall of certain Nellcor Puritan Bennett 980 ventilator systems. The systems affected use software versions...
View ArticleClik here to view.
Puritan Bennett 980 Ventilator Recalled
The FDA has announced a Class I recall of the Puritan Bennett 980 Ventilator System manufactured by Covidien. According to the agency’s notice, the product’s circuit board may have cracks resulting...
View ArticleBuilding a Better Alerts Management System
When it comes to keeping tabs on recall alerts, everybody needs to be involved. That was a key takeaway during a January 16 educational session at the annual symposium of the California Medical...
View ArticleHuman Error Triggers Recall of GE MRI Systems
On February 18, the FDA published a Class 1 recall of GE Healthcare MRI systems with superconducting magnets. The recall, which affects nearly 13,000 magnetic resonance imaging units, was prompted by...
View ArticleFDA to Speed Posting of Product Recalls
By William A. Hyman, ScD Manufacturers—which are supposed to report their actions to the U.S. FDA—initiate the overwhelming majority of medical device recalls. The FDA subsequently analyzes the product...
View ArticleProduct Recall Management 101
Best practices for HTM professionals By Mike Murray and Arthur Zenian As part of your overall biomedical equipment management strategy, you should maintain a product recall process that allows your...
View ArticleReady for Recalls
Dealing with device recalls can be a challenge for any hospital, but new regulations and technologies are starting to make this work a little easier. By Chris Hayhurst As a biomedical engineer with a...
View ArticleStudy: Managers Rely on Physicians to Screen Out Medical Device Defects
Results of a new behavioral study into what influences the decision to recall a defective product found that medical device firm managers may rely on their physician-customers to screen out detectable...
View ArticleMedtronic Announces Voluntary Field Corrective Action for Ventilator Series
Medtronic is notifying customers worldwide of a voluntary field corrective action—a software update—for its Puritan Bennett 980 (PB980) ventilator series. The software updates the external USB Drive...
View ArticleStryker Launches Voluntary Field Action for Certain Lifepak 15...
Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15...
View ArticleFDA Issues Draft Guidance Regarding Voluntary Recalls
The U.S. FDA announces that it has taken new steps to handle how voluntary recalls are managed across many industries, including the medical device sector. Melinda K. Plaisier, the FDA associate...
View ArticleFDA Recalls Medtronic Insulin Pumps Due to Cyber Concerns
The FDA is warning patients and healthcare providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models...
View Article
