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U.S. Department of Health and Human Services

Class 2 Device Recall Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT

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  Class 2 Device Recall Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT see related information
Date Initiated by Firm July 16, 2008
Date Posted November 05, 2008
Recall Status1 Terminated 3 on November 24, 2015
Recall Number Z-0213-2009
Recall Event ID 49440
510(K)Number K061994  
Product Classification Physiological Monitors - Product Code MSX
Product GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT with L-WEB05 software.

GE Healthcare 8200 West Tower Avenue, Milwaukee, WI 53223

Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda network or Unity Network and Web Viewer clients.

Web Viewer can be used for viewing or otherwise processing information from several bedside monitors or other networked devices.

Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other network devices.

Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.
Code Information serial numbers: 5221922, 5221925, 5221927, 5221929, 5221930, 6104032, 6104033, 6131575, 6172651, 6173193, 6241778, 6334201, 6334204, 6393453, CB8717D5D6, CZC53003BG, CZC5391VGC, CZC5460C7C, CZC5460C7D, CZC5460C7G, CZC5460C7L, CZC5462BTV, CZC5462BV0, CZC5462BV1, CZC5462HW2, CZC5462HW3, CZC5472F8K, CZC5472F8M, CZC5492LJT, CZC5492LKJ, CZC5492LKN, CZC5492LLF, CZC5492LLK, CZC5510Y68, CZC5510Y6C, CZC5510Y6F, CZC5510Y6K, CZC5521M4L, CZC5521M4N, CZC603076D, CZC603076H, CZC603076K, CZC603076P, CZC603076S, CZC6030772, CZC61030G7, CZC61030H1, CZC6103GG, CZC6130L2Q, CZC6130L32, CZC6130L39, CZC61544V7, CZC61544VS, CZC61544VX, CZC6181MT3, CZC6181MTW, CZC6261MWN, CZC62803T2, CZC62803TB, CZC63128X3, CZC6322Q7J, CZC6322Q7M, CZC6322Q7Z, CZC6322Q83, CZC6322Q87, CZC6391G9Y, CZC6394DG9, CZC6394DGD, CZC6394DH1, CZC6394DH5, CZC6394DH8, CZC6394DHD, CZC64006J8, CZC64006J9, CZC64006K2, CZC64006KF, CZC64006KJ, CZC64006L1, CZC64006L4, CZC64006L8, CZC642559P, CZC64511LJ, CZC64511LV, CZC64511M5, CZC64511M8, CZC6482WJW, CZC6482WK3, CZC6482WK4, CZC6482WK5, CZC6482WK6, CZC6482WKN, CZC6482WKV, CZC6482WKW, CZC6482WL0, CZC6482WL4, CZC6482WL7, CZC6482WLC, CZC6482WML, CZC7080QJ1, CZC7080QJQ, CZC7080QJX, CZC7080QK3, CZC7080QKB, CZC7105QDQ, CZC7105QDW, CZC7105QF5, CZC7105QFH, CZC7105QFN, CZC7105QFP, CZC7132V6S, CZC7132V6X, CZC7132V78, CZC7132V7L, CZC7132V84, CZC713ZV7Q, CZC721264N, CZC7212G4V, CZC7212G4W, CZC7215008, CZC721500L, CZC724149Q, CZC724149R, CZC72414BG, CZC7244NX6, CZC7244NX9, CZC7244NXB, CZC7244NXL, CZC7244NXW, CZC7250WMY, CZC7250WN5, CZC7272RLM, CZC7363P30, CZC7363P31, CZC7363P33, CZC7363P3L, CZC7364RRJ, CZC7364RRW, CZC7364RRX, CZC7364RS6, CZC7364RS7, CZC7364RSM, CZC7364RSW, CZC7364RT1, CZC7364RT7, CZC7364RTX, CZC7364RV7, CZC74146LV, CZC7414GDW, CZC7414GDY, CZC7414GF0, CZC7414GF6, CZC7414GFK, CZC7414GGJ, CZC7414GJ0, CZC7414GJ5, CZC7414GJF, CZC7414GJG, CZC7414GJK, CZC7414GK2, CZC7414GK4, CZC7414GK5, CZC7414GK6, CZC7414GK8, CZC7414GK9, CZC7414GKB, CZC7414GKD, CZC7414GKF, CZC7414GKG, CZC7414GKH, CZC7414GL0, CZC7414GL9, CZC7414GLD, CZC7414GLM, CZC7414GLZ, CZC7414GM1, CZC7414GM2, CZC7414GM3, CZC7414GM5, CZC7414GM6, CZC7414GM9, CZC7414GMG, CZC7414GMJ, CZC7414GMK, CZC7414GMN, CZC7414GMQ, CZC7520RZK, CZC7520S0S, CZC7520S1D, CZC7520S24, CZC7520S26, FRB4210XRV, FRB4210XSF, FRB4250SX1, FRB4250T03, FRB4250T05, FRB4250T0B, FRB4250T0G, FRB426012F, FRB4260132, FRB426013Y, GB8627CWKP, GB8627CWLE, GB8627CWM9, GB8627CWMW, GB8627CWNF, GB8627CWNS, GB8627CWPT, GB8627CWR7, GB8627CWRM, GB8627CWS0, GB8627CWSJ, GB8627CWTH, GB8627CWTX, GB8627CWX1, GB8627CWXP, GB8627CX06, GB8627CX0N, GB8627CX11, GB8627CX1B, GB8627CX1P, GB8627CX22, GB8627CX29, GB8627CX2M, GB8627CX2W, GB8627CX31, GB8717D5D0, GB8717D5D1, GB8717D5D2, GB8717D5D3, GB8717D5D4, GB8717D5D5, GB8717D5D7, GB8717D5D8, GB8717D5D9, GB8717D5DA, GB8717D5DB, GB8717D5WS, GB8717D5WV, GB8717D5WX, GB8717D5WY, GB8717D5X1, GB8717D5X3, GB8717D5X4, GB8717D5X5, GB8717D5X7, GB8717D5X8, GB8717D5X9, GB8717D5XA, GB8717D5XB, GB8747301C, GB8747301D, GB8747301H, GB8747301K, GB8747301L, GB8747301N, GB8747301T, GB8747301X, GB8747301Y, GB87473028, GB8747302A, GB8747302J, GB8747302K, GB8747302M, GB8747302N, GB87473030, GB87473031, GB87473034, GB8747303C, GB8747303D, GB8747303J, GB8747303K, GB8747303T, GB8747303Y, GB87473043, GB87473047, GB8747304A, GB8747304E, GB8747304K, GB8813FKF9, GB8813FKFH, GB8813FKFM, GB8813FKFS, GB8813FKH3, GB8813FKH7, GB8813FKHO, GB8813FKHW, GB8813FKJ2, GB8813FKJA, GB8813FKJE, GB8813FKJK, GB8813FKJP, GB8820NIK2
Recalling Firm/
Manufacturer		 GE Healthcare
Kuortaaneenkatu 2
Helsinki Finland
Manufacturer Reason
for Recall		 Issue 1 -Possible failure of CIC Pro audible alarms: Requests for telemetry defaults from Mobile Care Server could cause excessive CIC Pro memory consumption. This excessive memory consumption may lead to potential loss of audio at the CIC or a system reset or reboot. Issue 2 - Mobile Care software/Mobile Viewers don not recognize ApexPro FH Telemetry transmitter: Mobile Care server does not ac
FDA Determined
Cause 2		 Software design
Action Consignees contacted via a GE Healthcare Urgent Medical device Correction letter dated 8/26/08 and supplemental instruction for installation of software" Mobile care server with software, L-WEB05 and iCentral with software, L-NET05 supplemental Instruction for installation". The letter was addressed to Healthcare Administrator/Risk manger, chief of Nursing and director of Biomedical engineering / IT. The letter also described the problem, affected Products,and Short Term Recommendations .
Quantity in Commerce 292
Distribution Worldwide Distribution --- USA including states of CALIFORNIA, IOWA, INDIANA, VERMONT, and WASHINGTON and countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CROATIA, CYPRUS, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MSX and Original Applicant = GE HEALTHCARE
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