Tandem sent me an email saying they have found a serious problem with the speakers on some Tandem TSlim pumps. If the speaker fails the pump shuts down with “Malfunction 16” and will not operate ever again. They are not issuing a recall despite “700 adverse events reported and 59 reported injuries.” They intend to issue a software update eventually that will spot the problem before the malfunction notice pops up.
You can check your pump’s serial number here to see if you are affected.
Thanks for the info and links @Randy . I was able to check the s/n of my pump to see if it was affected. 
I also received. I took it as they were going to fix the issue with a software update.
Yep, my pump is one of those affected. I don’t use the speakers except when I accidentally miss a vibration alert. But I have had the vibration mechanism malfunction at least twice 
Not in a way that made the pump unusable, but had to call to log the issue and go through the reboot steps anyway. They said if it happens one more time I’ll get a replacement…
I checked and mine is not on the list. My pump is 4 years and 7 months. I wonder if this issue is for newer pumps.
They are “fixing” the issue by pushing out software that monitors the speaker’s current draw for changes and gives you a longer warning period rather than just shutting down abruptly. That lets you contact them for a new pump before it dies. No recall. If you are on a six month trek in Nepal, just take a spare pump. If you never use your speaker I don’t know if it would work or not. All of us need to have a backup plan anyway, and most people are in places where they can get an overnight Fedex.
@CarlosLuis, my older backup pump was on the list, but I don’t know the manufacturing date.
I’m not sure when my manufacture date was, but I got this pump in November 2022.
Can I use my pump as a backup when I get a new one in December? Will C IQ and the phone app work or will it be a dumb pump?
I was pleasantly surprised when I got my new one two years ago and they let me continue to update the older one. I had paid out of pocket for my first one because the alternative was a Medtronic. I don’t think there are any guarantees, however. Being able to keep it current on Control IQ makes it a much more useful backup!
Thanks,Randy.
This is indeed a type of recall Randy, one that does not require product to be pulled out of the field and returned to the mfr. In the medical device world, the term “recall” is typically used when product is physically pulled from the field and returned to the mfr. When the problem can be fixed remotely or in the field, the terms “field correction” or field corrective action" are typically used as is often the case with software corrections.
The term “adverse event” as it relates to medical devices often causes confusion too. An adverse event does not necessarily mean the malfunction caused injury. Legally it means that if the malfunction were to recur, it could cause injury. This makes it mandatory for mfrs to report these events to FDA, even when no injury or harm has taken place. From the notification, it appears that 59 of the 700 did cause some kind of harm to patients. This will weigh in on how FDA classifies this action. Also whether FDA agrees with how Tandem is handling this situation.