The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by t
FDA device recall Z-1214-2015 · posted 2015-02-26 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp
- Action taken
- Consignees were notified of the issue via telephone and site visit by GE Healthcare IT Field Engineers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 128 systems
- Distribution
- Distributed US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV, and
- Date initiated
- 2013-02-18
- Date posted
- 2015-02-26
- Date terminated
- 2016-05-16
- Location
- Barrington, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY PACS SYSTEM (K043415) | Ge Medical Systems Information Technologies | 2005-01-21 |