Category: Recalls

Medtronic 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 performance and its impact on Graphical User Interface (GUI) functionality and the labeling displayed on the GUI during ventilator use, Medtronic said in a statement.

Read More

Study: Managers Rely on Physicians to Screen Out Medical Device Defects

Results of a new 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 defects, in lieu of issuing a recall. The study also found that some managers appear to hesitate to recall a product until the root cause of the defect is clearly understood, because this can reduce recall costs to the firm.

Read More

Identifying Recalls and Non-Recalls

In the latest Soapbox column, biomedical engineering educator and expert, William Hyman, takes a closer look at the logistical challenges and difficult decisions triggered by the FDA’s ‘Do Not Use’ recalls on medical devices. Don’t miss out.

Read More

Ready for Recalls?

Although medical device recalls can be a challenge for any hospital, new regulations and technologies are starting to make this work a little easier, says seasoned writer Chris Hayhurst in October’s cover story. So, is your facility ready for a product recall? Assess your readiness here.

Read More

Product Recall Management 101

As part of your overall biomedical equipment management strategy, you should maintain a product recall process that allows your organization to react quickly and decisively to a recall situation, enBio Corp.’s Mike Murray and Arthur Zenian say. Below, they share how to accomplish this.

Read More