In early August, the FDA issued a Class 2 Device Recall for Visibly’s Online Refraction Vision Test, stating that the company did not receive authorization from the FDA to market the product. According to the recall, Visibly has already initiated the recall.
This back and forth between the Chicago-based startup (formerly known as Opternative) and the FDA has been going on for a couple of years....
Intel subsidiary Basis is recalling its Peak fitness tracking watch. The company halted production of the device at the end of June due to an overheating issue that affected just 0.2 percent of the watches on the market, but had hoped to fix the issue with a software update. Now, developers are throwing in the towel, issuing a voluntary recall, and offering full refunds.
"We had hoped to update...
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...
GreatCall's Jitterbug service just had a major setback -- the easy-to-use mobile phone service makes use of one phone, the Samsung "Jitterbug" and the U.S. Consumer Product Safety Commission announced a voluntary recall of Samsung "Jitterbug" phones sold between March 2008 and May 2009. That makes for a voluntary recall of some 160,000 Jitterbug phones.
The reason? Some of the phones -- when in...
