FDA Device recall Z-2244-2026
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9
- FDA Device
- Class II
- ongoing
- Published 2026-06-03
On 2026-06-03 the FDA classified a Class II recall of GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9 by Ge Medical Systems Information Technologies, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2244-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-24 |
| Published | 2026-06-03 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems Information Technologies |
| Distribution | n/a |
Product
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason
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).
Identifiers
| code_info | Serial #/Sales Order #: SS920500004SA, SS920500005SA, SS920500003SA, SS920500006SA, SS921120011SA, SS921120019SA, SS921120015SA. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-23 · Ge Medical Systems Information Technologies - PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
All Ge Medical Systems Information Technologies recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2244-2026%22
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