GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
USGE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Recalling Firm: GE Medical Systems Information Technologies Inc
Motivo del Retiro / Peligro
TranslatedGE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Descripción del Producto e Identificación
TranslatedGE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98938 |
| Address 1 | 3114 N Grandview Blvd |
| Code info | no UDI, Serial Number or Sales Order Number: KSA7013962, KSA5646256, KSA5646267, KSA5646268, KSA5646321, KSA5646328, KSA5646242, KSA5646251, KSA5646257, KSA5646284, KSA5646289, KSA5646295, KSA5646297, KSA5646306, KSA5646314, KSA6689326, KSA6689333, KSA6689378, KSA7162600, KSA7162603, KSA7162619, KSA7162631, KSA7769614, KSA6017390, KSA6569811, KSA6569814, KSA6569816, KSA6569853, KSA6569856, KSA6569866, KSA6569875, KSA6569879, KSA6569896, KSA7162612, KSA7162623, KSA7162662, KSA6409156, KSA6409176, KSA6409177, KSA6409181, KSA6420012, KSA6420057, KSA6420088, KSA6420106, KSA7013897, KSA5646292, KSA6409244, KSA7162605, KSA6808884, KSA7304364, KSA7304449, KSA7304452, KSA6590164, KSA7304435, KSA6954216, KSA6954221, KSA6626645, KSA6689380, KSA6808843, KSA6808843, KSA6808873, KSA6808874, KSA6808897, KSA6808897, KSA6623262, KSA6945167, KSA6017455, KSA7096908, KSA7096928, KSA7096932, KSA7096935, KSA7096940, KSA7096941, KSA7096946, KSA7096959, KSA7096971, KSA7096976, KSA7096985, KSA7096986, KSA709... [TRUNCATED] |
| Postal code | 53188-1615 |
| Report date | 20260603 |
| Product type | Devices |
| Product quantity | 1249 units |
| Reason for recall | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260424 |
| Initial firm notification | Letter |
| Center classification date | 20260528 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
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 GuideQ1:What should I do immediately if I own or bought GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjuncti...?
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
- DistributionWorldwide distribution.
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🚨 SAFETY ALERT: GE Medical Systems Information Technologies Inc - GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Check if your household is affected: https://therecallfile.com/es/recalls/ge-healthcare-carescape-telemetry-server-ark-2250l-north-america-ref-5/FDA-Z-2245-2026
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