FDA Device recall Z-0175-2020
ApexPro Telemetry Server System
- FDA Device
- Class II
- ongoing
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of ApexPro Telemetry Server System by Ge Healthcare, citing 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) u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0175-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-08-30 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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 effectiveness of the medical procedures administered.
Reason
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.
Identifiers
| code_info | 1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M…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, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, J1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0175-2020%22
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