Startseite/Alle Rückrufe/FDA-Z-2476-2026
FDA DevicesClass II

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX

Veröffentlicht: 24. Juni 2026Rückruf-ID: Z-2476-2026Kategorie: MedizinprodukteLand: Vereinigte Staaten
US
Medical DeviceFDA DevicesUSUS

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX

Recalling Firm: GE Medical Systems, LLC

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

Produktbeschreibung & Identifikation

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX

Additional Source Details

FieldValue
CityWaukesha
StateWI
Event id98986
Address 13000 N Grandview Blvd
Code infoUDI-DI: 010084068211686221; Serial Numbers: TAB24430068SA TAB24430069SA TAB24430070SA TAB24430071SA TAB26011006SA TAB26011009SA TAB26021001SA TAB26061022SA TABW63370 TAB24300033SA TABV60214 TABW63378 TAB24240010SA TABV62327 TABA70043 TABA70053 TABA70054 TABA70055 TABZ72515 TABV60081 TABV60219 TABV60221 TABV60223 TABV60224 TAB25351023SA TAB25501502SA TAB25501503SA TAB25501530SA TAB25501531SA TAB26021501SA TAB26021503SA TAB26101502SA TAB26101503SA TAB26101507SA TAB26101509SA TAB26101510SA TAB26101511SA TAB26101512SA TAB26101513SA TAB26101515SA TAB26101516SA TAB26101517SA TAB26101519SA TAB26101520SA TAB26101521SA TABX63854 TABX63855 TABX63856 TAB25111019SA TAB24160010SA TABY70926 TABY70987 TABX63393 TAB24280002SA TABV60007 TABV60203 TABW63326 TABX62677 TABX62757 TABX63717 TABX63718 TABY71177 TAB24180045SA TAB24180046SA TAB24180047SA TAB24280001SA TAB25081073SA TAB25081074SA TABB70452 TABB70464 TABB70550 TABB70572 TABX63665 TABX63769 TABX63776 TAB24330009SA TAB24330010SA TAB24330011SA TAB2... [TRUNCATED]
Postal code53188-1615
Report date20260624
Product typeDevices
Product quantity23430 units
Reason for recallGE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260501
Initial firm notificationLetter
Center classification date20260617

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 Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant...?

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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Übersicht

  • Rückrufendes UnternehmenGE Medical Systems, LLC
  • StatusOngoing
  • RisikostufeClass II
  • DistributionWorldwide - US Nationwide distribution.
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

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🚨 SAFETY ALERT: GE Medical Systems, LLC - Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX

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