GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The device is intended for use by
FDA device recall Z-0705-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety. 1 - User may notice an image from a different patient, or an image from the current patient with title information from a different patient. 2 Incorrect measurements/calculations on images, when viewed on the off-line review station. As a re
- Action taken
- The firm, GE Healthcare" sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 20, 2011 to its customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, Contact Information and actions to be taken. The customers were instructed to ensure that all potential users in their facility are made aware of this safety notification and recommended actions and to follow the safety instructions noted in the letter. If you have any questions or concerns, contact your local GEHC service representative at 1-800-321-7937 (USA/Canada).
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 894
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AK, AZ, ALR, CA, CO, CT, FL, GA, IL, IN, IA, LA, LME, MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TIN, TX, UT,
- Date initiated
- 2012-01-03
- Date posted
- 2012-01-11
- Date terminated
- 2013-01-10
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOGIQ E9 (K110943) | GE Healthcare | 2011-07-22 |