GE ApexPro disaster recovery USB kits may lose patient monitoring
GE HealthCare ApexPro v5.0 Software Disaster Recovery USB Kits are being recalled because a persistent NO COMM or OFF NETWORK condition can cause loss of ECG and SpO2 monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where patient ECG and SpO2 monitoring may be lost, a risk of harm with no injuries reported in the source.
Plain-English summary
GE HealthCare APEXPRO v5.0 ARK2250 Software Disaster Recovery USB Kit, REF 2108523-01, orderable by GE Service only and used with the ApexPro CARESCAPE Telemetry Server (CTS) v5.0, is being recalled. The action covers 14 units.
GE HealthCare has become aware of a situation, which it describes as unlikely, where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server 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. The FDA classified the action as Class II.
Distribution was worldwide. The kits are used by service personnel rather than sold to consumers.
Facilities and service teams should identify affected units using the REF number and serial or sales order numbers in the recall notice and follow the instructions issued by GE HealthCare.
The recalled product
- Product
- GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- UDI none
- Serial number or Sales Order number SS921120014SA
- SS921120017SA
- SS921120021SA
- SS921120018SA
- SS921120020SA
- SS920390001SA
- SS921120007SA
- SS921120008SA
- SS921120012SA
- SS921120016SA
- SS920500001SA
- SS920500002SA
- SS921120009SA
- SS921120010SA.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by GE Medical Systems Information Technologies Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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