GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT...
GE Healthcare began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-0213-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- GE Healthcare
- 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.
- Product code
- MSX System, Network And Communication, Physiological Monitors
- 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
- Root cause tag
- software
- FDA root cause
- 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.
- Product codes and lots
- 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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
