Class 2 Device Recall GE Precision 500D Classical RadiographicFluoroscopic

• Date Initiated by Firm: October 04, 2007
• Date Posted: September 04, 2008
• Recall Status: Terminated on August 09, 2012
• Recall Number: Z-0369-2008
• Recall Event ID: 46680
• 510(K)Number: K011624
• Product Classification: x-ray fluoroscopic sytem - Product Code JAA
• Product: GE Precision 500D Classical Radiographic-Fluoroscopic; X-ray System. ; Model #2289299-2, with console computer and touch screen fullly integrated. the GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System is used to perform radiographic and fluoroscopic x-ray examinations.
• Code Information: 2023567F53 203576P500 205783PRF4 208227ROOM6 208678500D 210916BRF1 218741P500 252847PR7 256880CR4 260463PRE 269657P500D 281401T500D 303450RM3DIG 303825P500 303837P50010 305325RM10 305325RM7 352401RF1 352402RM1 352596RF1 386HPORF 402481BP500 404785P500D1 406863P500 414649ENDOP1 419291FL1 503513RM4 504897RF 505627RF1 509525VP500 510267VARF 510797RM3 512943GTP500 570574PREC1 570574PREC2 580548P500B 601445PRF1 601853RF1 601853RF2 605333RM8 606759P500 606789PRE 606878P500 608756P500 609597P500 610378RF3 610378RF4 615446NRF 617414ENDO1 617789RFE 618964MPRF1 631427P500D 631444P500D 651220P500 662751RF1 671GMHAP5D 678454P500D1 678454P500D2 703558ROOM3 706335RF1 706774UB8 707443STJ2 712472P500 713441MMRF1 716878WCRF2 732840P5D 757314SRM1 757398RM1 773962PR1 801292PR5 801465RM1 801479RM5 805546P500 812825PRE500 814938RM1 815741P500 817545P500 818409RF1 828213AIRF2 843374P500 845561P500D 850431RM9 850934P500A 863902RF 864366ARF2 870864P500 908647500D 910452CFR3 918274500D 937440RM2 972981P500 973661500D 973676500D 979282P500D MONT500D USFREEDOM500 KW1013RX15 KW1085RX01 00490FLU01 C5123628 FP970407 00824FLU02 00471FLU03 00090FLU02 05229FLU02 705356PR500
• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by the patient. Patient will receive a lower dosage irradiation time which will result in indication of cumulative air kerma higher than that to which the patient was actually exposed.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: A customer letter "GE Healthcare Product Safety Notification" dated 10/4/07 was distributed to customers informing them of the safety issue. A Field Modification Instructions (FMI 10806) was issued to the field for the Precision 500D product to install a sofware upgrade to correct the issue. This correction was released in October 2007.
• Quantity in Commerce: 106
• Distribution: AL, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, ITALY, Kuwait, Great Britan, Spain and Canada.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = JAA and Original Applicant = GE MEDICAL SYSTEMS