Recall Z-0175-2020 ยท DSI Detector And Alarm, Arrhythmia
GE Healthcare, LLC
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.
| Date | Oct 23, 2019 (initiated Aug 30, 2019) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | GE Healthcare notified customers on about 08/30/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were made aware of the below six (6) potential safety issues along with corresponding safety instructions. Safety Issue #1: Telemetry patients monitored on a Central Station or in combination monitoring mode with a CARESCAPE B850/650/450, DASH 3000/4000/5000, or SOLAR 8000M/I bedside monitor under certain conditions can experience the following: ECG arrhythmias configured to MEDIUM (WARNING) or lower alarm priority occurring before and after a NO TELEM condition may not re-activate |
| Quantity | 22,438 (17,971 US; 4,467 OUS) devices total |
| Distribution | Worldwide distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of ALGERIA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000779 | APEXPRO TELEMETRY SYSTEM General Electric Medical Systems Information Techn, May 18, 2000 |
| K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM General Electric Medical Systems Information Techn, May 7, 2002 |
| K032369 | MODIFICATION TO: APEXPRO TELEMETRY SYSTEM Ge Medical Systems Information Technologies, Aug 15, 2003 |
| K033365 | APEXPRO FH TELEMETRY SYSTEM Ge Medical Systems Information Technologies, Nov 6, 2003 |
| K080251 | APEXPRO TELEMETRY SYSTEMS Ge Medical Systems Information Technologies, Jun 20, 2008 |