ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry S

FDA device recall Z-0175-2020 · posted 2019-10-23 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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 after the NO TELEM condition resolves. This issue may result in delayed treatment for a potentially life-threatening ECG arrhythmia event. There have been no reported injuries as a result of this issue. Safety instructions included that the monitor can continue being used under these instructions: 1. Configure the VTACH arrhythmia to HIGH (CRISIS) alarm priority. 2. Any ECG arrhythmia of clinical concern should be configured to HIGH (CRISIS) alarm priority. 3. Make sure that the ECG HR alarm is set to priority of MEDIUM (WARNING) or higher to ensure proper alarming. 4. Ensure that your ECG HR limits are appropriately configured for your patient population. Safety Issue #2: 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: A NO TELEM INFORMATIONAL (MESSAGE) indication may remain displayed on the Central Station instead of a HIGH (CRISIS) LEADS FAIL or a MEDIUM (WARNING) NO TELEM alarm. This issue can result in delayed treatment for a potentially a life-threatening event, as a failure to notice prolonged loss of ECG monitoring. There have been no reported injuries as a result of this issue. Safety instructions included that the monitor can continue being used by following these instructions: For a N

Root cause

Software design

Status

Open, Classified

Product code

DSI

Quantity affected

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, N

Date initiated

2019-08-30

Date posted

2019-10-23

Location

Waukesha, WI

Related 510(k) clearances