Prestige VH
FDA Device Recall #Z-0913-2017 — Class II — November 21, 2016
Recall Summary
| Recall Number | Z-0913-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 21, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | Total for all products 1,598 (USA 824, OUS 774) |
Product Description
Prestige VH
Reason for Recall
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
Distribution Pattern
US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
Lot / Code Information
Mfg. Lot or Serial # System ID Not Available 708425PREST 00000063646YY4 314525APR 00000034238YY6 910249LRF3 00000023833YY7 919472CGRFA 00000063653YY0 724284R4 00000052120YY3 713442KPDRS 00000063577YY1 509458DR10 00000048069YY9 AH4317XR04 00000052117YY9 AH3221XR06 00000026253YY5 AH5681XR02 Not Available CS1029RX01 00000113920MO3 EG1112RX05 00000023862YY6 M4159446 00000034208YY9 M4160037 Not Available M1875113 00000039660YY6 M4500608 00000048049YY1 M2880713 00000026209YY7 M4046528 Not Available M2838405 Not Available M2663805 00000089618MO3 M4202921 00000031488YY0 M9624214 00000023814YY7 M4496929 00000023829YY5 M4496929 Not Available B4192927 00000034269YY1 HC2834XR11 00000063668YY8 HC1627XR14 00000026202YY2 HC0393XR02 00000023796YY6 HC0760XR01 00000026216YY2 PC0545XR04 Not Available 490314XR02 Not Available MC5880XR03 Not Available CC2149XR02 Not Available IS1002RX01 00000063686YY0 IE1012RX03 00000063667YY0 IE1025RX02 Not Available IE1006RX07 00000063609YY2 A5250603 Not Available A5127805 00000034283YY2 NO1004RX01 00000026203YY0 NO1041RX01 Not Available NO1104RX01 00000048004YY6 NO1016RX02 00000080076YY3 PPR00132 00000063713YY2 PPR59013 00000026248YY5 RU1306RX01 00000063560YY7 CE165306 00000063616YY7 05074FLU02 00000063755YY3 38853103XRMET
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 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.