AliveCor 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.” Keep reading>>