The FDA Enforcement Report for the week of February 27, 2013, lists the ongoing Class II Recall of the Philips HeartStart XL+ defibrillator/monitor.
Intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation, the HeartStart XL+ involves model number 861290. Philips initiated the recall on January 28, 2013 because the product may become locked out of clinical use.
It distributed the product in the US and worldwide, including Algeria, Angola, Belgium, Bulgaria, Colombia, Cyprus, France, Gabon, Germany, Hong Kong, Tanzania, and more.
For a full list and details, read the report online.
