GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT with L-WEB
FDA device recall Z-0213-2009 · posted 2008-11-05 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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
- Action taken
- 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 .
- Root cause
- Software design
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 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, FR
- Date initiated
- 2008-07-16
- Date posted
- 2008-11-05
- Date terminated
- 2015-11-24
- Location
- Helsinki, Finland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE (K061994) | GE Healthcare | 2006-08-11 |