GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/
FDA device recall Z-0524-2013 · posted 2012-12-14 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
- Action taken
- Consignees were sent on 2/17/2012 three GE Healthcare "Important Product Information" letters dated 10/17/ 2011. The letters were addressed to Healthcare Administrator/Risk Manager, Director of Biomedical Engineering, and Chief of Nursing. The letters described the Issue, Instructions, Affected Product Details, Product Correction and Contact Information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 10,250
- Distribution
- Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,V
- Date initiated
- 2012-02-17
- Date posted
- 2012-12-14
- Date terminated
- 2013-12-03
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (K071073) | Ge Medical Systems Information Technologies | 2007-05-11 |