GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data
FDA device recall Z-1164-2013 · posted 2013-04-23 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated October 5, 2011, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to contact their local GE Healthcare Service Representative if they have questions or concerns. They may also contact GE Healthcare Call Center , United States or Canada at 800-437-1171. Other countries 262-896-2890. For questions regarding this recall call 262-513-4122.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 11
- Distribution
- Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.
- Date initiated
- 2011-10-06
- Date posted
- 2013-04-23
- Date terminated
- 2014-02-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XELERIS 2 PROCESSING AND REVIEW WORKSTATION (K051673) | GE Medical Systems | 2005-07-18 |