Reported Oct 30, 2019 · Ongoing
ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- ApexPro Telemetry Server System
- Also identified as Modification ToApexPro Telemetry System and ApexPro
- FH Telemetry System - Product UsageThese 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
- Lot codes and dates
- 1
- Product Code3F, No UDI Number
- Serial Numbers
1,820 of 1,820 codes
M13F1043GB23F1531GB23F1532GB23F2216GA23F1290GB23F1324GM13F1152GM13F1153GM13F1154GM13F1155GM13F1164GM13F1165GM13F1166GM13F1168GM13F1169GL13F0687GD23F1925GD23F1968GE23F2074GE23F2075GB23F1402GM13F1059GM13F1173GM13F1109GC23F1815GA23F1260GJ13F0272GC23F1607GD23F1981GM13F0968GL13F0683GL13F0576GJ13F0274GB23F1302GK13F0437GC23F1793GD23F1943GM13F1094GB23F1495GK13F0481GL13F0571GB23F1304GC23F1808GD23F1899GM13F1151GJ13F0098GJ13F0099GJ13F0100GC23F1594GM13F1099GB23F1439GJ13F0229GL13F0600GK13F0499GK13F0500GK13F0501GL13F0623GL13F0624GL13F0625GB23F13886
- Product Code4T
- UDI Number (Serial Numbers)
446 of 446 codes
Not Applicable (F24T0254G)Not Applicable (F24T0259G)Not Applicable (F24T0264G)Not Applicable (F24T0279G)Not Applicable (A44T4691G)Not Applicable (A44T4713G)Not Applicable (C44T4931G)Not Applicable (D34T2574G)Not Applicable (H34T3263G)Not Applicable (H34T3264G)Not Applicable (H34T3266G)Not Applicable (H34T3267G)Not Applicable (H34T3268G)Not Applicable (H34T3270G)Not Applicable (H34T3272G)Not Applicable (H34T3274G)Not Applicable (M24T1660G)Not Applicable (M24T1661G)Not Applicable (M24T1662G)Not Applicable (M24T1672G)Not Applicable (M24T1710G)Not Applicable (M24T1716G)Not Applicable (M24T1718G)Not Applicable (M24T1721G)Not Applicable (M34T4314G)Not Applicable (M34T4315G)Not Applicable (M34T4316G)Not Applicable (M34T4321G)Not Applicable (M34T4360G)Not Applicable (M34T4368G)Not Applicable (M34T4482G)Not Applicable (M34T4215G)Not Applicable (M34T4216G)Not Applicable (J34T3725G)Not Applicable (J34T3752G)Not Applicable (J34T3755G)Not Applicable (M34T4340G)Not Applicable (G24T0384G)Not Applicable (K24T1151G)Not Applicable (L24T1274G)Not Applicable (L24T1284G)Not Applicable (L24T1377G)Not Applicable (L24T1401G)Not Applicable (L34T4001G)Not Applicable (A44T4739G)Not Applicable (G24T0475G)Not Applicable (A44T4573G)Not Applicable (C34T2261G)Not Applicable (B44T4778G)Not Applicable (F24T0081G)Not Applicable (F24T0292G)Not Applicable (F24T0294G)Not Applicable (F24T0296G)Not Applicable (F24T0297G)Not Applicable (F24T0318G)Not Applicable (F34T2928G)Not Applicable (K24T1003G)Not Applicable (L34T4174G)Not Applicable (F34T3021G)Not Applicable (C34T2336G)
- Amount recalled
- 22,438 (17,971 US; 4,467 OUS) devices total
Where it was sold
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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