Terminated

GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK TM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.

FDA Recall Z-3075-2011 · Posted 2011-08-25

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeMHX

Date Initiated2011-07-05

Date Terminated2012-09-11

Product Quantity8029 devices

Reason for Recall

GE Healthcare has recently become aware of an issue with the Dash 3000/4000/5000 patient monitors configured with the 802.11b wireless LAN option that may impact patient safety. The Dash monitor may exhibit reboots on some networks when the 802.11b wireless LAN option is used to connect to the hospital wireless LAN infrastructure. This reboot results in a loss of patient monitoring for approxima

Firm Action

GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. GE recommended actions that should be taken by a qualified service representative. For any questions regarding the medical device correction or identification of affected items contact Technical Support at 1-800-558-7044 or customers should contact their local Service Representative. UPDATE: A second letter dated 12/13/11 was sent on 1/20/12 to consignees. The revised letter provides an update to the safety instructions and product correction.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI and the countries of UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVENIA, SINGAPORE, SAUDI A ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, KUWAIT, JAPAN, ITALY, ISRAEL, INDIA, GERMANY, FRANCE, FINLAND, ESTONIA, ECUADOR, DENMARK, CANDA, BELGIUM AUSTRIA, AUSTRALIA, and ALGERIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073462MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIESGe Medical Systems Information Technologies · 2008-01-11

Official Source

View FDA Recall →

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