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FDA DevicesClass II

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

Published: August 12, 2026Recall ID: Z-2876-2026Category: Medical DevicesCountry: United States
US
Medical DeviceFDA DevicesUSUS

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

Recalling Firm: GE Medical Systems Information Technologies Inc

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Reason for Recall / Hazard

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.

Product Description & Identification

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

Additional Source Details

FieldValue
CityMilwaukee
StateWI
Event id99400
Address 19900 W Innovation Dr
Code infoGTIN 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, VU... [TRUNCATED]
Postal code53226-4856
Report date20260812
Product typeDevices
Product quantity163 units
Reason for recallSoftware 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260629
Center classification date20260804

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Recalling FirmGE Medical Systems Information Technologies Inc
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: GE Medical Systems Information Technologies Inc - GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

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https://therecallfile.com/recalls/ge-healthcare-mac-vu360-ref-part-number-2030361-023-electrocardiograph/FDA-Z-2876-2026
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