—#151918

Product

RFX

FDA product code: IXR — Table, Radiographic, Tilting
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K760466
Affected lot / code info: Mfg. Lot or Serial # System ID Not Available 818963RM4 00000026176YY8 213266SFX Not Available 209384MMRF 00000047956YY8 INSIGHTXR010 Not Available 818891VA1 Not Available 818891VA2 Not Available 2025761X46 Not Available 2025761X40 Not Available 813633RFX Not Available 813971RF6 Not Available 708259NWRF7 00000034249YY3 913596PR4 00000023702YY4 606327ADV Not Available 504867LRF2 Not Available 318388RF3 00000023806YY3 617735B6 00000022210YY9 313576RM1663 00000022218YY2 313576RM3622 Not Available 313576RM3645 Not Available 218726SMRF2 Not Available 601865RF1 Not Available 601865RF2 Not Available 601376OP3 Not Available 919681DB3 Not Available 919250WM9 00000026194YY1 706791D7 Not Available 914964SJRF 00000071239YY8 405271PRF4 00000022200YY0 215576RF18 00000128622MO8 615871SRF1 Not Available 817965HADV Not Available 713364W03 Not Available 206244RM2 00000022207YY5 EG1055VA01 00000022140YY8 SK1005RX05 00000023856YY8 AE1020RX01

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Consignees 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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2016-11-21
Terminated: 2017-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151918. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.