Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG...
FDA Device Recall #Z-2584-2018 — Class II — May 24, 2018
Recall Summary
| Recall Number | Z-2584-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 24, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 42 units total |
Product Description
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Reason for Recall
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Distribution Pattern
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
Lot / Code Information
a. HVY WAUK, Serial Number CJRBX1700130CN (System ID 770836EVO, UDI 01008406821097961117120021CJRBX1700130CN), Serial Number CJRBX1800005CN (System ID 918635REVO, UDI 01008406821097961118010021CJRBX1800005CN); b. LONG HINO, Serial Number RE36A1800042YC (System ID 864560REV1, UDI 01008406821097961118020021RE36A1800042YC), Serial Number RE36A1800036YC (System ID 216448REVO, UDI 01008406821097961118020021RE36A1800036YC); c. LONG WAUK, Serial Number CJRBX1800037CN (System ID 740383REVO, UDI 01008406821097961118040021CJRBX1800037CN), Serial Number CJRBX1800022CN (System ID 317415REVO, UDI 01008406821097961118020021CJRBX1800022CN), Serial Number CJRBX1800013CN (System ID 423844REVO, UDI 01008406821097961118010021CJRBX1800013CN), Serial Number CJRBX1700132CN (System ID 719557REVO, UDI 01008406821097961117120021CJRBX1700132CN), Serial Number CJRBX1800008CN (System ID 510248EVOCT, UDI 01008406821097961118010021CJRBX1800008CN); d. MID BJG, Serial Number 500918HM8 (System ID 918623REVO, UDI Not Available), Serial Number CBCGG1700116HM (System ID 704834EVO, UDI 01008406821097961117120021CBCGG1700116HM), Serial Number CJRBX1800022CN (System ID 864560REVOL, UDI 01008406821097961118020021CJRBX1800022CN), Serial Number CBCGG1700097HM (System ID 979BRENCT1, UDI 01008406821097961117110021CBCGG1700097HM), Serial Number CBCGG1700094HM (System ID 405779REVO, UDI 01008406821097961117110021CBCGG1700094HM), Serial Number CBCGG1700107HM (System ID 217283HREVO, UDI 01008406821097961117110021CBCGG1700107HM), Serial Number CBCGG1700102HM (System ID 303SWDEVO, UDI 01008406821097961117110021CBCGG1700102HM), Serial Number CBCGG1700112HM (System ID 908788EVO, UDI 01008406821097961117120021CBCGG1700112HM), Serial Number 490670HM7 (System ID 718226REVO, UDI Not Available); e. MID WAUK, Serial Number CJRBX1800017CN (System ID 478454EVO, UDI 01008406821097961118020021CJRBX1800017CN), Serial Number CJRBX1800028CN (System ID 210MASHREVO, UDI 01008406821097961118030021CJRBX1800028CN), Serial Number CJRBX1800014CN (System ID 601968REVO, UDI 01008406821097961118010021CJRBX1800014CN).
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
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.