FDA Device recall Z-1669-2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Sci…

FDA Device
Class II
ongoing
Published 2022-09-07

On 2022-09-07 the FDA classified a Class II recall of The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Sci… by Boston Scientific, citing there is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1669-2022
Classification	Class II
Status	ongoing
Initiated	2022-07-07
Published	2022-09-07
Last updated	2026-09-13 11:56 UTC
Company	Boston Scientific
Distribution	n/a

Product

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

Reason

There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

Identifiers

code_info	UPN: 00802526434723, Serial Numbers: 051026, 051075, 051091, 051121, 051146, 051156, 051171, 051182, 051207, 051232,… UPN: 00802526434723, Serial Numbers: 051026, 051075, 051091, 051121, 051146, 051156, 051171, 051182, 051207, 051232, 051236, 051239, 051270, 051320, 051335, 051358, 051367, 051370, 051374, 051413, 051418, 051425, 051432, 051435, 051456, 051459, 051473, 051478, 051486, 051487, 051495, 051501, 051511, 051533, 051535, 051549, 051552, 051558, 051561, 051580, 051584, 051592, 051593, 051612, 051623, 051626, 051632, 051640, 051655, 051696, 051727, 051745, 051763, 051769, 051770, 051784, 051808, 051818, 051846, 051850, 051863, 051906, 051924, 051931, 051989, 051997, 052018, 052022, 052030, 052034, 052088, 052131, 052145, 052202, 052320, 052460, 054970, 054981, 054993, 054996, 055007, 055016, 055020, 055023, 055037, 055041, 055048, 055059, 055065, 055066, 055069, 055070, 055079, 055086, 055089, 055098, 055113, 055117, 055122, 055132, 055142, 055148, 055154, 055157, 055172, 055174, 055191, 055193, 055205, 055211, 055213, 055214, 055219, 055227, 055246, 055248, 055253, 055256, 055270, 055277, 0

code_info

UPN: 00802526434723, Serial Numbers: 051026, 051075, 051091, 051121, 051146, 051156, 051171, 051182, 051207, 051232,…

UPN: 00802526434723, Serial Numbers: 051026, 051075, 051091, 051121, 051146, 051156, 051171, 051182, 051207, 051232, 051236, 051239, 051270, 051320, 051335, 051358, 051367, 051370, 051374, 051413, 051418, 051425, 051432, 051435, 051456, 051459, 051473, 051478, 051486, 051487, 051495, 051501, 051511, 051533, 051535, 051549, 051552, 051558, 051561, 051580, 051584, 051592, 051593, 051612, 051623, 051626, 051632, 051640, 051655, 051696, 051727, 051745, 051763, 051769, 051770, 051784, 051808, 051818, 051846, 051850, 051863, 051906, 051924, 051931, 051989, 051997, 052018, 052022, 052030, 052034, 052088, 052131, 052145, 052202, 052320, 052460, 054970, 054981, 054993, 054996, 055007, 055016, 055020, 055023, 055037, 055041, 055048, 055059, 055065, 055066, 055069, 055070, 055079, 055086, 055089, 055098, 055113, 055117, 055122, 055132, 055142, 055148, 055154, 055157, 055172, 055174, 055191, 055193, 055205, 055211, 055213, 055214, 055219, 055227, 055246, 055248, 055253, 055256, 055270, 055277, 0

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1669-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.