GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for
FDA device recall Z-1849-2013 · posted 2013-08-01 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
- Action taken
- Starting on November 9, 2012, GE Healthcare, will plan to update the software on all of the affected GE LOGIQ e Ultrasound systems that were distributed at no cost to the customer. As an effectiveness check, we will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures. No Customer letter was sent. Further questions please call (262) 513-4122.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 588
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the
- Date initiated
- 2012-11-09
- Date posted
- 2013-08-01
- Date terminated
- 2014-09-15
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE LOGIQ I, LOGIQ E AND VIVID E (K113690) | GE Healthcare | 2011-12-29 |