FDA DevicesClass II
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product...
Published: June 3, 2026Recall ID: Z-2242-2026Category: devicesCountry: US
Reason for Recall / Hazard
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).
Product Description & Identification
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; 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 | UDI (01)00840682144773(10)v5.0.2R1C1, Serial Number or Sales Order Number: SS924160026SA, SS921080002SA, SS923080001SA, SS923080006SA, SS922460008SA, SS921320004SA, SS921320010SA, SS921320012SA, SS922120001SA, SS921210005SA, SS921060024SA, SS921060026SA, SS924290077SA, SS923290011SA, SS923290012SA, SS923290013SA, SS923290014SA, SS921520004SA, SS922080001SA, SS922080002SA, SS922120002SA, SS922120003SA, SS924200022SA, SS924450085SA, SS924220065SA, SS921210002SA, SS921210003SA, SS924220066SA, SS924050001SA, SS922170005SA, SS924160027SA, SS924160028SA, SS924160029SA, SS924160031SA, SS924160032SA, SS924160033SA, SS921300003SA, SS921420015SA, SS921420016SA, SS921520002SA, SS920520004SA, SS922250001SA, SS923510002SA, SS923510003SA, SS924160023SA, SS924170017SA, SS924200031SA, SS924200032SA, SS924090011SA, SS924090016SA, SS924090018SA, SS924090020SA, SS924090021SA, SS924090024SA, SS924140003SA, SS924140006SA, SS924140011SA, SS924140012SA, SS924140014SA, SS924170006SA, SS924170007SA, SS9241700... [TRUNCATED] |
| Postal code | 53188-1615 |
| Report date | 20260603 |
| Product type | Devices |
| Product quantity | 476 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 |
Overview
- Recalling FirmGE Medical Systems Information Technologies Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution.