GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare
FDA device recall Z-0519-2008 · posted 2008-01-17 · Terminated
Recall details
- Recalling firm
- General Electric Medical Systems Information Technology
- Reason for recall
- Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors.
- Action taken
- A "GE Urgent Medical Device Correction" letter was sent to consignees on 10/16/2007. The letter described the problem and product involved. The letter also gave short term recommendations. A long term solution is being worked on by GE and will be announced when determined.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 3, 116
- Distribution
- Worldwide-USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV
- Date initiated
- 2007-11-08
- Date posted
- 2008-01-17
- Date terminated
- 2011-12-10
- Location
- Wauwatosa, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER (K062976) | Ge Medical Systems Information Technologies | 2007-03-16 |