FDA Device recall Z-0610-2020

Medfusion Syringe Pump, Model 4000

FDA Device
Class I
terminated
Published 2019-12-18

On 2019-12-18 the FDA classified a Class I recall of Medfusion Syringe Pump, Model 4000 by Smiths Medical Asd, citing there is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and inte….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0610-2020
Classification	Class I
Status	terminated
Initiated	2019-10-28
Published	2019-12-18
Last updated	2026-09-13 11:55 UTC
Company	Smiths Medical Asd
Distribution	CO, MD, NY

Product

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

Reason

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

Identifiers

code_info	Serial numbers: 2039045, 2039062, 2039082, 2039084, 2039093, 2039122, 2039128, 2039132, 2039133, 2039137, 2039145, 203… Serial numbers: 2039045, 2039062, 2039082, 2039084, 2039093, 2039122, 2039128, 2039132, 2039133, 2039137, 2039145, 2039151, 2039153, 2039158, 2039164, 2039174, 2039178, 2039181, 2039182, 2039183, 2039187, 2039202, 2039203, 2039204, 2039208, 2039209, 2039210, 2039211, 2039212, 2039216, 2039217, 2039220, 2039221, 2039223, 2039225, 2039226, 2039228, 2039231, 2039232, 2039234, 2039235, 2039236, 2039238, 2039239, 2039246, 2039247, 2039248, 2039250, 2039252, 2039259, 2039290, 2039291, 2039292, 2039295, 2039305, 2039307, 2039308, 2039312, 2039313, 2039315, 2039317, 2039323, 2039325, 2039360, 2039373, 2039394, 2039407, 2039416, 2039419, 2039420, 2039422, 2039435, 2039437, 2039446, 2039453, 2039456, 2039460, 2039461, 2039462, 2039463, 2039464, 2039465, 2039466, 2039469, 2039473, 2039478, 2039483, 2039485, 2039487, 2039490, 2039494, 2039502, 2039503, 2039516, 2039517, 2039545, 2039551, 2039904, 2039910, 2039970, 2040014, 2040029, 2040034, 2040040, 2040047, 2040050, 2040054, 2040068, 2040074, 20

code_info

Serial numbers: 2039045, 2039062, 2039082, 2039084, 2039093, 2039122, 2039128, 2039132, 2039133, 2039137, 2039145, 203…

Serial numbers: 2039045, 2039062, 2039082, 2039084, 2039093, 2039122, 2039128, 2039132, 2039133, 2039137, 2039145, 2039151, 2039153, 2039158, 2039164, 2039174, 2039178, 2039181, 2039182, 2039183, 2039187, 2039202, 2039203, 2039204, 2039208, 2039209, 2039210, 2039211, 2039212, 2039216, 2039217, 2039220, 2039221, 2039223, 2039225, 2039226, 2039228, 2039231, 2039232, 2039234, 2039235, 2039236, 2039238, 2039239, 2039246, 2039247, 2039248, 2039250, 2039252, 2039259, 2039290, 2039291, 2039292, 2039295, 2039305, 2039307, 2039308, 2039312, 2039313, 2039315, 2039317, 2039323, 2039325, 2039360, 2039373, 2039394, 2039407, 2039416, 2039419, 2039420, 2039422, 2039435, 2039437, 2039446, 2039453, 2039456, 2039460, 2039461, 2039462, 2039463, 2039464, 2039465, 2039466, 2039469, 2039473, 2039478, 2039483, 2039485, 2039487, 2039490, 2039494, 2039502, 2039503, 2039516, 2039517, 2039545, 2039551, 2039904, 2039910, 2039970, 2040014, 2040029, 2040034, 2040040, 2040047, 2040050, 2040054, 2040068, 2040074, 20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0610-2020%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.