GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Informati
FDA device recall Z-0891-2007 · posted 2007-06-06 · Terminated
Recall details
- Recalling firm
- General Electric Medical Systems Information Technology
- Reason for recall
- Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot .
- Action taken
- GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07 that explained the short and long term solutions and that the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 software.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 5,190 Units
- Distribution
- Nationwide
- Date initiated
- 2007-01-24
- Date posted
- 2007-06-06
- Date terminated
- 2011-12-10
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K032370) | Ge Medical Systems Information Technologies | 2003-08-13 |