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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Prestige II

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 Class 2 Device Recall GE Healthcare Prestige IIsee related information
Date Initiated by FirmNovember 21, 2016
Create DateDecember 23, 2016
Recall Status1 Terminated 3 on September 26, 2017
Recall NumberZ-0911-2017
Recall Event ID 75851
510(K)NumberK943805 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductPrestige II
Code Information  Mfg. Lot or Serial # System ID 00000128555MO0 850526JR3 00000089643MO1 305227PRESTIGE1 00000094666MO5 305227PRESTIGE2 00000063792YY6 708216REM1 00000100104MO9 219416PRE 00000118238MO5 317338SVP 00000119906MO6 228314RF 00000113951MO8 662513RF2 Not Available 662513RF1 00000063697YY7 919472CGRFB 00000113961MO7 718262REM1 00000052137YY7 843692PRES 00000010115MO5 803778RF1 00000128514MO7 423493PRF4 Not Available 901226R9 Not Available 204623RF1 00000128614MO5 519685REM 00000063717YY3 905895RM3 00000113955MO9 905358REM 00000128544MO4 519631REM 00000128595MO6 326582XF1 00000063685YY2 082408040013 00000063685YY2 082408040013 00000063761YY1 082408100085 00000063716YY5 EG1024RX01 Not Available HDAR01XR02 00000128613MO7 IS1001RF01 00000063688YY6 A5181620 Not Available A5487204 00000063749YY6 B5130612 Not Available 0850080467 Not Available LY1006XR03 00000119921MO5 0853080154 00000063700YY9 0853080151 00000063700YY9 0853080151 00000119921MO5 0853080154 Not Available 38828380XRNOR 00000063753YY8 38811857XRAND 00000063767YY8 0859080008 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactStephanie Cass
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionConsignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in CommerceTotal for all products 1,598 (USA 824, OUS 774)
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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