Data Foundry

Medical device recalls 2019

ApexPro Telemetry Server System — Class II medical device recall Z-0175-2020

Ongoing recall by GE Healthcare, LLC, reported 2019-10-30, distributed nationwide. May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center m

Recall numberZ-0175-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2019-08-30
Classified2019-10-23
Reported by FDA2019-10-30
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, BE, BG, BH, BM, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LK, LT, LV, MA, MX, MY, NL, NO, NZ, PA, PH, PL, PT, QA, RO, RU, SA, SE, SG, SK, TH, TR, TW, VE, VN, ZA
UPC / GTIN / UDI-DI00840682109260
Serial numbers00840682109260SE213410181GA, 00840682109260SE217350041SA, 14GA, A0GU1745G, A0GU1746G, A0GU1747G, A0GU1748G, A0GU1749G, A0GU1750G, A0GU1751G, A0GU1752G, A0GU1754G, A0GU17556, A0GU1755G, A0GU1756G, A0GU1757G, A0GU1758G, A0GU1759G, A0GU1762G, A0GU1763G, A0GU1765G, A0GU1766G, A0GU1768G, A0GU1769G, A0GU1770G and 475 more

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 for recall

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.

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-0175-2020. 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.