What happens when an FDA-cleared app gets "recalled"?

By Jonah Comstock
09:40 am
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AliveCor Heart MonitorAliveCor recalled Version 2.1.2 of its AliveECG iOS app under an FDA Class III recall according to an FDA posting that went up this month. But in actuality, the "recall," which happened in mid-January, was little more than a run-of-the-mill buggy app update, which the company patched within two days.

"If you read the definitions of recall, if you, as a manufacturer of medical devices, place a product on the market that does not meet its design intent, that doesn’t function as intended, then you remove that device from the market, that’s a recall," Albert Boniske, Director of Regulatory Affairs at AliveCor, told MobiHealthNews. "In this case, we didn’t ship any products. We put an app into the AppStore that had a bug in it that was not identified during QA, that caused the app to crash. ... We immediately pulled that down and we re-uploaded another one."

A Class III recall is used in cases where a product is found to not function as intended, but not in a way that presents a health risk to the public. FDA-cleared apps are covered under medical device rules, and sometimes those rules function bizarrely in the context of apps. In this case, those rules required AliveCor to inform the FDA about the recall, leading to a posting on the FDA website nearly a month after the fact.

Back in January, the company informed users of the problem via Twitter and Facebook, though neither posting referenced the FDA or mentioned the recall in those terms.

"We wanted to notify our customers of what had gone wrong, we didn’t feel it necessary to specify the term recall in that Facebook post," Boniske said. "Just 'Users, this is what happening, we’re fixing the issue for you.' Just to keep them apprised of that information."

AliveCor's AliveECG app is a companion app for the AliveCor Heart Monitor. It records and displays the readings picked up by the device and, as of last September, also includes an algorithm that automatically detects atrial fibrillation. AliveCor also recently received clearance for two more algorithms, to be incorporated into future app updates: One which detects normal readings and one which detects interference or improper use of the device.

The recall says the app has 5,600 affected users, which Boniske says is AliveCor's best estimate of their number of active iOS users, based on Apple's download data and their own interaction with customers.

App recalls are still ground for the FDA. A Class II recall was issued back in 2012 for Diamigo, a Sanofi Aventis diabetes management app that was mistakenly released globally, rather than only in Brazil as intended. In that case Apple actually sent a push message to inform those who had downloaded the app not to use it for insulin calculations and to delete it from their phone.

An AliveCor spokesperson said that some customers complained initially, but most were impressed by how quickly AliveCor resolved the issue. Boniske added that because the AliveCor Heart Monitor is not a life-support or life-sustaining device, no one was endangered by the bug.

"Certainly, this is nothing AliveCor is proud of. We put a product out that was buggy and it crashed immediately. That’s certainly egg on our face and we certainly don’t want that to happen ever again, and we’ve taken corrective actions to make sure that sort of thing doesn’t happen again," he said."... But, fortunately, because it is an app and we are able to get expedited review through the iTunes when emergency situations like this come through, we were able to fix the issue quite quickly. We strive to support our customers as fast as we could and that’s as fast as we could do it in this case."

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