Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is inte
FDA device recall Z-0731-2014 · posted 2014-01-14 · Terminated
Recall details
- Recalling firm
- Ge Healthcare It
- Reason for recall
- There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once ter
- Action taken
- GE Healthcare sent an Important Product Information letter dated September 15, 2012 to affected customers. The letter identified the affected product problem and actions to be taken. GE Healthcare will provide a patch to 3.2.X and 4.0 Systems to remediate the issue. For questions contact your local GEHC-IT service representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 748 units
- Distribution
- Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,
- Date initiated
- 2012-09-15
- Date posted
- 2014-01-14
- Date terminated
- 2016-06-10
- Location
- Barrington, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY PACS SYSTEM (K043415) | Ge Medical Systems Information Technologies | 2005-01-21 |