Data Foundry

Medical device recalls 2026

GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL — Class II medical device recall Z-2242-2026

Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2026-06-03. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involv

Recall numberZ-2242-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Medical Systems Information Technologies Inc, Waukesha, WI, United States
Recall initiated2026-04-24
Classified2026-05-28
Reported by FDA2026-06-03
Quantity476 units
UPC / GTIN / UDI-DI00840682144773
Model numbers2063702-101

Product

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)

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).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2242-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.