Z-2876-2026Class II

GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

Name: Z-2876-2026 GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Creator: GE Medical Systems Information Technologies Inc
Published: 2026-06-29
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2026-06-29 / Open, Classified / root cause: software

FDA source

GE Medical Systems Information Technologies Inc began a recall of GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph on 2026-06-29. FDA classified it as Class II and gives the reason as "Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2876-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-29
Posted: 2026-08-04
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Product code: DPS Electrocardiograph
Reason for recall: Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 6/29/2026 via US mail. The notice explained the issue, potential risk, and requested the following: 'Actions to be taken by Customer/User You can continue to use your device. Pending corrections from GE HealthCare, after pressing the Order Refresh icon do not rely on automatic closure of the Preview and or Review screen when: " patient has been disconnected, and " at least 2 minutes of system inactivity If this occurs, do the following to clear all patient information data: " On the Preview screen, select Reject > Start New Patient " On the Review screen, select Done > Start New Patient NOTE: Be certain Start New Patient is selected to clear all patient information data. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 30123 Digital Response Form or print, fill out manually, scan, and email to [email protected]." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 163 units
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.
Product codes and lots: GTIN 00198953107263, Serial Numbers: VU221150078SA, VU222400121SA, VU223230048SA, VU222520132SA, VU219400033SA, VU219400034SA, VU219400045SA, VU219400055SA, VU220270027SA, VU220510048SA, VU220510078SA, VU221100161SA, VU221100181SA, VU221150116SA, VU222120212SA, VU222120220SA, VU222120239SA, VU222120243SA, VU222120249SA, VU222120250SA, VU222120253SA, VU222120258SA, VU222120260SA, VU222120261SA, VU222120266SA, VU222120269SA, VU222140004SA, VU222200296SA, VU222520114SA, VU223120014SA, VU223120041SA, VU223420119SA, VU224050158SA, VU224070091SA, VU224200028SA, VU224420159SA, VU224520140SA, VU225170260SA, VU225420050SA, VU225520037SA, VU226040025SA, VU419320042SA, VU421490135SA, VU421490151SA, VU421490153SA, VU421490155SA, VU421490159SA, VU422460150SA, VU422460194SA, VU422460203SA, VU422460303SA, VU422480164SA, VU422500239SA, VU422500240SA, VU422500241SA, VU422500242SA, VU422500244SA, VU422500245SA, VU422500246SA, VU422500247SA, VU422500248SA, VU422500249SA, VU422500250SA, VU422500251SA, VU422500254SA, VU422500260SA, VU422500261SA, VU422500264SA, VU422500265SA, VU422500266SA, VU422500267SA, VU422500269SA, VU422510038SA, VU422510049SA, VU422510060SA, VU422510061SA, VU423050080SA, VU423050178SA, VU423220064SA, VU423220225SA, VU425130020SA, VU425130022SA, VU425130024SA, VU425130084SA, VU425130085SA, VU421490060SA, VU421490063SA, VU421490065SA, VU421490068SA, VU421490069SA, VU421490097SA, VU421490122SA, VU422460206SA, VU422460209SA, VU422460215SA, VU422460218SA, VU422460219SA, VU422460302SA, VU422460304SA, VU422460269SA, VU422460273SA, VU422460274SA, VU422460278SA, VU422460282SA, VU422460284SA, VU422480071SA, VU422460306SA, VU422460285SA, VU422480070SA, VU422460287SA, VU422460301SA, VU422480066SA, VU422480078SA, VU422480083SA, VU422480084SA, VU422480085SA, VU422480086SA, VU422480087SA, VU422480088SA, VU422480099SA, VU422480110SA, VU422480111SA, VU422480120SA, VU422480121SA, VU422480125SA, VU422480127SA, VU422480128SA, VU422480129SA, VU425130087SA, VU224200105SA, VU222120088SA, VU223130071SA, VU223220135SA, VU223220174SA, VU219490019SA, VU226050047SA, VU225460222SA, VU225460237SA, VU225470012SA, VU225470018SA, VU225470022SA, VU225470023SA, VU225470024SA, VU225470030SA, VU225470034SA, VU225470035SA, VU225470038SA, VU221050014SA, VU223310039SA, VU223450002SA, VU223310012SA, VU222190155SA, VU225060039SA, VU225060040SA, VU225060046SA, VU225060038SA, VU226154224SA, VU225500096SA, VU225500106SA, VU225500109SA, VU225500019SA, VU225500031SA, VU225500076SA.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2876-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2876-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-04

Product code DPS

K173830Class IIMAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. / cleared 2018-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)