Recall Z-0363-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.
| Date | Nov 15, 2010 (initiated Oct 5, 2010) |
| Status | Terminated |
| Reason | Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer |
| Root cause | Software design |
| Action | GE Healthcare issued an "Urgent Medical Device Correction" letter dated September 17, 2010 to consignees. The letter was addressed to Hospital Administrator, Head of Biomedical Engineering and Nursing Manager. The letter described the product, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Service representatives will updates all of the affected Transport Pros with PDM that were distributed. Customers may contact GE at 262-548-2731 about this correction. |
| Quantity | 3256 |
| Distribution | Worldwide Distribution: Domestic in the states of AL, AZ, AR, CA,CT, CO, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, and WY, and Internation in the countries of BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, CANADA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE Ge Medical Systems Information Technologies, May 11, 2007 |