GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" cl
FDA device recall Z-1600-2009 · posted 2009-09-04 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Tecnology
- Reason for recall
- GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.
- Action taken
- A GE Healthcare "Urgent Medical Device Correction" letter dated February 24, 2009 was sent to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Affected units will be replaced with new units by GE Field Service team members. For questions regarding this notice or experience a failure to restart the device, please contact GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 352
- Distribution
- Worldwide Distribution -- US (states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD,KY, MI, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, WV and WI), AUSTRIA, AUSTRALIA, CANADA, CZECH
- Date initiated
- 2009-03-10
- Date posted
- 2009-09-04
- Date terminated
- 2012-10-16
- Location
- Wauwatosa, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER (K062976) | Ge Medical Systems Information Technologies | 2007-03-16 |