Merlin PCS 3650 programmer Model 3330 software
Check against the official notice below — it lists the full affected range.
St. Jude Medical is recalling the Merlin PCS 3650 programmer Model 3330 with software version v25.X.X due to a software anomaly. When a pacing capture Decrement Test is performed in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may fail to terminate the test and restore the permanent programmed pacing parameters under very specific circumstances. Approximately 30,069 devices with this software have been distributed worldwide, including throughout all U.S. states and numerous countries.
The affected programmer units include specific serial numbers ranging from 11339 to 11886. The recall document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Reason for recall: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters. Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina, Australia, AUSTRIA, Bahrain, Bangladesh, BELGIUM, Brazil, Bulgaria, Canada, Chile, COLOMBIA, COSTA Quantity: 30,069 devices with software Lot/code info: Model 3330 software Version: v25.X.X UDI: 05414734509725 System Affected Serial Numbers: 11339 11341 11344 11345 11346 11347 11348 11350 11351 11352 11353 11355 11358 11359 11360 11362 11364 11368 11372 11373 11374 11375 11379 11380 11382 11385 11386 11387 11489 11491 11492 11494 11496 11497 11498 11499 11501 11502 11505 11507 11508 11509 11510 11512 11513 11516 11517 11518 11522 11524 11530 11534 11536 11537 11542 11545 11550 11552 11554 11555 11556 11557 11558 11561 11563 11564 11573 11574 11576 11577 11579 11582 11583 11587 11589 11590 11591 11593 11597 11598 11600 11602 11604 11605 11607 11611 11613 11614 11618 11619 11621 11622 11623 11624 11625 11626 11631 11633 11634 11637 11639 11642 11643 11647 11650 11652 11654 11655 11658 11661 11663 11664 11666 11667 11669 11671 11673 11675 11676 11677 11678 11679 11682 11683 11686 11687 11688 11689 11691 11694 11695 11696 11697 11700 11703 11704 11707 11708 11711 11712 11716 11718 11720 11721 11722 11724 11725 11726 11729 11730 11732 11733 11734 11735 11736 11745 11748 11749 11750 11751 11756 11757 11758 11759 11760 11762 11763 11765 11768 11769 11770 11771 11772 11773 11774 11778 11779 11780 11781 11782 11785 11788 11792 11793 11794 11796 11797 11801 11808 11809 11811 11812 11816 11818 11821 11822 11823 11824 11828 11829 11830 11832 11833 11836 11839 11840 11841 11842 11843 11844 11846 11847 11848 11849 11851 11853 11854 11855 11856 11858 11859 11861 11864 11866 11867 11868 11869 11870 11875 11877 11880 11881 11883 11884 11886 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.