FDA DevicesClass II

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

Publicado: 2 de septiembre de 2026ID de Retiro: Z-3038-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

Recalling Firm: GE Medical Systems Information Technologies Inc

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Motivo del Retiro / Peligro

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Descripción del Producto e Identificación

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

Additional Source Details

FieldValue
CityWaukesha
StateWI
Event id99536
Address 13114 N Grandview Blvd
Address 2N/A
Code infoGTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.
Postal code53188-1615
Report date20260902
Product typeDevices
Product quantity15 units
Reason for recallSoftware issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260720
Initial firm notificationLetter
Center classification date20260827

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 PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353?

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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Resumen

  • Empresa ResponsableGE Medical Systems Information Technologies Inc
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionUS: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: GE Medical Systems Information Technologies Inc - PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

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https://therecallfile.com/es/recalls/portrait-core-services-software-v1-0-5-ref-5697353/FDA-Z-3038-2026
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