GE Healthcare…

Date posted by the FDA

Aug. 25, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

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.

Reason

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

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.

Quantity

8029 devices

Codes and lots

Parent SN SBG07088084GA SBG07121347GA SD009513350GA SD009513846GA SD009513847GA SD009524000GA SD009524022GA SD010127715GA SD010470400GA SBG06525985GA SBG06525988GA SBG06526380GA SBG06526381GA SBG07026902GA SBG07026903GA SD010148692GA SBG06526328GA SBG07121291GA SBG07142197GA SBG07142199GA SBG07142200GA SBG07173225GA SBG07173226GA SD009057911GA SD007346050GA SD010127681GA SD010138425GA SD010148740GA SD010429302GA SD010429303GA SD010429304GA SD010449616GA SD010449617GA SD010449618GA SD010449619GA SD010449620GA SD010449621GA SD010449622GA SD010449623GA SD010449624GA SD010449625GA SD010449626GA SD010449627GA SD010449628GA SD010449629GA SD010449630GA SD010127738GA SD010127747GA SD010127749GA SD010189722GA SD010189723GA SD010429041GA SD010429042GA SD010429043GA SD010429044GA SD010429045GA SD010429046GA SD010429047GA SD010429048GA SD010429049GA SD010429050GA SD010429051GA SD010429091GA SD010429092GA SD010429093GA SD010429094GA SD010429095GA SD010429096GA SD010429156GA SD010429157GA SD010429158GA SD010429159GA SD010429160GA SD010429161GA SD010429162GA SD010429163GA SD010481107GA SD010481108GA SD010481109GA SD010481118GA SD010512325GA SD007366627GA SD010459752GA SD010459762GA SD010459763GA SD010459764GA SD010459765GA SD010459766GA SD010459771GA SD010459772GA SD009244563GA SD010127805GA SD010138467GA SD010138484GA SD010148676GA SD010148677GA SD010148688GA SD010148689GA SD010148691GA SD010189649GA SD010189650GA SD010189655GA SD010189656GA SD010189660GA SD010189662GA SD010189663GA SD010189672GA SD010189688GA SD010189689GA SD010189690GA SD010189692GA SD010189693GA SD010189697GA SD010189699GA SD010189705GA SD010189708GA SD010189709GA SD010189713GA SBG07026904GA SBG07026905GA SBG07027014GA SBG07027015GA PA1669553 PA1669554 PA1669559 PA1669560 SBJ08062466GA SBJ08062467GA SD008087509GA SD008087518GA SD009513381GA SD009513383GA SD009119398GA SD010116608GA SD010116609GA SD010116610GA SD010116612GA PA1863389 PA1863390 PA1863391 PA1863392 PA1863393 PA1863394 PA1863395 PA1863396 PA1863397 PA1863398 PA1864326 PA1864327 PA1864328 PA1864329 PA1864330 PA1864331 PA1864332 PA1864333 PA1864334 PA1864335 PA1864336 PA1864337 PA1927648 PA1927649 PA1927650 PA1927652 PA1927653 PA1927654 PA1927655 SD009513221GA SD009513223GA SBG06056893GA SBG06026033GA SBG06505112GA SBG05260079GA SBG05320089GA SD009057919GA SD009119475GA SD009119627GA SD009119628GA SD009119629GA SD009119631GA SD009119633GA SD009119639GA SD009129871GA SD009129872GA SD010459747GA SD010459751GA SD009119394GA PA1669555 SD009119637GA SD009119730GA SD009129868GA SD010459769GA SBG06316168GA SD009119630GA SBG06441002GR SBG07077688GA SD009513320GA SD009513892GA SD009513895GA SBG06223385GA SBG06439722GA SBG06462549GA SBG06172165GA SD009513351GA SD009513352GA SD009523999GA SD009524001GA SD009524002GA SD009524003GA SD009524004GA SD009524005GA SD009524020GA SD009524023GA SD009524024GA SD009524026GA SD009223930GA SD009524178GA SD010127736GA SD008494636GA PA1669556 PA1669558 SD007251984GA SD007397784GA SBG06172209GA…

Recall started

July 5, 2011

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-3075-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-3075-2011. The agency record governs; check it and the company before acting.