The recalled devices were manufactured from May 2004 through February 2009 and distributed from May 2004 through February 9, 2009. The defibrillators that fall under the recall have serial numbers in which the last six numbers are under 200000. Defibrillators obtained prior to February 14, 2009 should have serial numbers under 200000 and fall under the recall.

The recall follows a series of letters sent in February and March 2009 to distributors and customers with recommendations and instructions for customers on specific steps to mitigate the identified problems with the device. The February letter instructed customers to replace their batteries every three years. The March follow-up letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels. The new software will detect and prevent potential battery problems that could develop with 123A Lithium batteries in the future.

Software upgrades can be found at www.zollaedplusbatteryhelp.com.

ZOLL will send an email notice to all customers who included their email address as part of their contact information. ZOLL will also publish information about the recall in industry magazines.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Source: FDA

SOURCE: Sprint Fidelis Lead Recall › FDA issues Class I recall on ZOLL heart defibrillator

The pressure from the FDA is long coming. In 1990, Congress ordered the more rigorous testing of medical devices before they became available for use, however the FDA never finished implementing the law, getting caught up in a federal loophole that allowed products that are “substantially equivalent” to combinations of other products marketed before 1976 to be sold. Thus, hundreds of new “Class C” devices were approved and made available for use. Class C is the FDA’s most risky category.

Products that currently fall in the Class C category include external heart defibrillators from Medtronic Inc., Royal Phillips Electronics NV and Zoll Medical Corp; dialysis catheters from Covidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; and a heart pump from Abiomed Inc.

The FDA’s recent action on the measure is spurred by the Government Accountability Office, which criticized the delay last January. The FDA will issue the regulations to the makers of the high-risk medical devices and based on the data, the agency will determine whether to reclassify devices to a less risky category or require the manufacturers to undergo further, more rigorous pre-market testing.

SOURCE: Sprint Fidelis Lead Recall › FDA to crack down on medical device manufacturers