United StatesThe Merlin Patient Care System (PCS) Merlin PCS 3650 programmer, Model 3330 software (GTIN 05414734509725; software versions 25.0.1–28.7.1) sold in the United States is affected and can be identified by Programmer Model 3650 and Software Model 3330. It was recalled because a software malfunction may occur during a pacemaker pacing capture threshold test, resulting in the programmer not successfully communicating the command to terminate the test.
What's being recalled
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Recalling firm: Abbott Medical, Sylmar, CA, United States.
How to identify it
Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
The hazard
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada