FDA Medical Device Recalls (openFDA)
GE Healthcare: 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.
- Recall number
- Z-0213-2009
- 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.
- Status
- Terminated
- Initiated
- 2008-07-16
- Posted
- 2008-11-05
- Terminated
- 2015-11-24
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K061994"]
- PMA numbers
- not on file
- Product code
- MSX
- Firm FEI
- not on file
- Firm city
- Helsinki
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28