GE Healthcare ApexPro Telemetry Server System Recall for Alarm Failure
GE Healthcare is recalling ApexPro Telemetry Server Systems because they may fail to provide visual or audible alarms for ECG arrhythmias, lead failures, or pulse oximetry issues.
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: The recall involves a medical device that may fail to provide critical alarms for patient monitoring, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling the ApexPro Telemetry Server System, which is also identified as a modification to the ApexPro Telemetry System and ApexPro FH Telemetry System. These systems are typically deployed in sub-acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of medical procedures.
The recall is due to a defect where the systems may not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL, or Pulse Oximetry (SpO2) under certain conditions. This failure could prevent healthcare providers from receiving necessary alerts regarding patient status.
A total of 22,438 devices are affected, with 17,971 in the United States and 4,467 outside the US. The devices were distributed worldwide, including nationwide across all US states and territories, as well as in numerous countries across Europe, Asia, the Americas, and the Middle East. Healthcare facilities should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effec
- Manufacturer
- GE Healthcare, LLC
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 (20)
- 1. Product Code: 3F
- No UDI Number
- Serial Numbers: M13F1043G
- B23F1531G
- B23F1532G
- B23F2216G
- A23F1290G
- B23F1324G
- M13F1152G
- M13F1153G
- M13F1154G
- M13F1155G
- M13F1164G
- M13F1165G
- M13F1166G
- M13F1168G
- M13F1169G
- L13F0687G
- D23F1925G
- D23F1968G
Distribution
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