Centricity Enterprise Archive is a software product for receiving, archiving and sending of medic...
FDA Device Recall #Z-0833-2015 — Class II — April 19, 2013
Recall Summary
| Recall Number | Z-0833-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 19, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ge Healthcare It |
| Location | Barrington, IL |
| Product Type | Devices |
| Quantity | 115 units |
Product Description
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).
Reason for Recall
GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.
Distribution Pattern
Nationwide Distribution including AZ, OH, WA.
Lot / Code Information
Centricity Enterprise Archive versions: 4.0.x
Other Recalls from Ge Healthcare It
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0748-2014 | Class II | Merge Mammo is a multi-modality, vendor-neutral... | Aug 26, 2013 |
| Z-0116-2014 | Class II | The Centricity PACS Workstation is intended for... | Jun 11, 2013 |
| Z-0330-2014 | Class II | The Centricity Laboratory System is intended to... | Mar 12, 2013 |
| Z-0620-2014 | Class II | The Centricity Laboratory System is intended to... | Mar 12, 2013 |
| Z-0337-2014 | Class II | Centricity Perinatal and Centricity Intensive C... | Mar 11, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.