Recalls

Audience: Fire departments, emergency medical services personnel, hospitals

Medical Device Recalls

December 20, 2017

Defibrillation Electrodes for Lifepak AEDs by Physio-Control: Class I Recall - Incorrect Placement Instructions for Infants Depicted on Artwork

April 13, 2017

FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm

April 27, 2010

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

Audience: Emergency medical personnel, consumers

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly:

• Power Off then On by itself.
• Power Off then NOT turn On.
• Power Off by itself requiring the operator to turn it back On.
• Stay powered On and not allow itself to be turned Off.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Online: www.fda.gov/MedWatch/report.htm 
• Phone: 1-800-332-1088
• Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178

Click here to read the complete MedWatch 2010 Safety summary, including a link to the Recall Notice.

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch.

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November 23, 2009

Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction

April 9, 2009

ZOLL AED Plus Defibrillator

ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. See the Zoll letter at link below for details.

Read the complete MedWatch 2009 Safety Summary, including links to the FDA notice and the Zoll customer click here.

Philips Heartstart Fr2+ Automated External Defibrillators - Recall

Philips and FDA notified healthcare professionals of the recall of 5,400 HeartStart FR2+ automated external defibrillators (AED) due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. The AEDs are used by trained responders and designated response teams to help treat sudden cardiac arrest.

The recalled units (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) were manufactured between May, 2007 and January, 2008. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs and set up a page on the Philips Website  with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.

Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at:

Philips Heartstart Fr2+ Automated External Defibrillators - Recall