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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Prestige SI

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 Class 2 Device Recall GE Healthcare Prestige SIsee related information
Date Initiated by FirmNovember 21, 2016
Create DateDecember 23, 2016
Recall Status1 Terminated 3 on September 26, 2017
Recall NumberZ-0912-2017
Recall Event ID 75851
510(K)NumberK943805 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductPrestige SI
Code Information  Mfg. Lot or Serial # System ID Not Available 310665PREST 00000047974YY1 1711 Not Available 708799SPHR 00000026137YY0 708216L11 Not Available 219886NLP Not Available 504380LP3 00000031369YY2 201754PRES Not Available 718250RM2 00000031404YY7 330385FL6 Not Available 803464PRES 00000026140YY4 AP5821XR04 Not Available 519837REM Not Available 905565REM 00000031306YY4 514468BPRESTIGE 00000052130YY2 514468BPRESTIGE 00000034288YY1 514495PRESTIGE Not Available M9864607 Not Available M4261103 00000048089YY7 A5218915 00000047968YY3 PER18303 
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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