We’ve recently made a couple of quality-related announcements.
The first was excellent news. We’ve been working hard to accelerate the availability of our software update for the field corrective action we announced last November. This is the large field action affecting more than 300,000 units worldwide, where the software update will enhance our self-test’s ability to detect an unlikely but serious component failure. Originally, we didn’t expect the update to be available until May, but we will now begin to make the update available to affected customers this month. Releasing the software update three months early is reassuring news for our customers … I want to recognize our employees, many of whom have been working around-the-clock for many weeks to make this happen.
The second bit of news wasn’t as positive, but in a way it signals the progress we’ve made in improving our quality systems. Last week we announced we would be doing another voluntary field action for certain of our AEDs. It’s not a large population (~12,200) and the costs are relatively modest (~$2-3M), but as always we are sorry to disappoint and inconvenience our business partners and customers. This action is notable because we discovered the issue (and took action) despite there being no reported problems in the field. That means our quality system is working as designed and our improvement initiatives are having an impact. Going forward, we will continue to enhance our quality systems so we can identify, correct, and prevent issues even sooner.
The other takeaway from this most recent recall is that Cardiac Science is committed to having the safest and most reliable devices in the industry. Our desire to act with an abundance of caution will sometimes result in our taking action quite early, before any issues become manifest in the field.
Because the costs of this action are relatively modest, our company’s turnaround plans will not be affected. We will continue to make substantial investments in new products, marketing, IT, and quality systems. In fact, we have 6 new product introductions planned for 2010.
I want to thank all our customers and business partners for your patience. I know it has been a challenging several months. We are committed to offering the best possible devices and sometimes that commitment requires that we take corrective actions. We greatly appreciate your loyalty and support.
Last 5 posts by Dave Marver
- Cardiac Science CEO on new products, new alliances, and new Japanese AED distribution partner - July 29th, 2010
- Cardiac Science CEO Dave Marver with Good News about the FDA Recall - July 19th, 2010
- Letter from Cardiac Science CEO Dave Marver regarding the FDA update - April 28th, 2010
- U.S. Representative Jay Inslee visits Cardiac Science - March 17th, 2010
- Dave Marver: Cardiac Science FDA Warning Letter Update - February 23rd, 2010
February 12th, 2010 at 4:33 pm
As they say, bad news is better than no news. Thanks for the excellent, constant communication with your distributors on this matter. That’s what matters. Onward.
February 12th, 2010 at 4:37 pm
Thank you, Diego. Yes, we’ve received a lot of positive feedback with this open approach.
As you say, onward!