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Open, Classified

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.

FDA Recall Z-0175-2020 · Posted 2019-10-23

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeDSI
Date Initiated2019-08-30
Product Quantity22,438 (17,971 US; 4,467 OUS) devices total

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.

Firm 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 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

Distribution Pattern

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, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, Indonesia, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, Malaysia, MEXICO, MOROCCO, Myanmar, NETHERLANDS, New Zealand, NORWAY, PANAMA, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, Russia, SAUDI ARABIA, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, Thailand, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, Viet Nam, YUGOSLAVIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080251APEXPRO TELEMETRY SYSTEMSGe Medical Systems Information Technologies · 2008-06-20K033365APEXPRO FH TELEMETRY SYSTEMGe Medical Systems Information Technologies · 2003-11-06K032369MODIFICATION TO: APEXPRO TELEMETRY SYSTEMGe Medical Systems Information Technologies · 2003-08-15K021325MODIFICATION OF APEXPRO TELEMETRY SYSTEMGeneral Electric Medical Systems Information Techn · 2002-05-07K000779APEXPRO TELEMETRY SYSTEMGeneral Electric Medical Systems Information Techn · 2000-05-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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