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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Precison 500D Classical R&F System

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  Class 2 Device Recall GE Healthcare, Precison 500D Classical R&F System see related information
Date Initiated by Firm August 01, 2007
Date Posted August 02, 2008
Recall Status1 Terminated 3 on September 10, 2008
Recall Number Z-0274-2008
Recall Event ID 47235
510(K)Number K011624  
Product Classification Image-intensified fluoroscopic x-ray system - Product Code JAA
Product Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.
Code Information Code Numbers:  00000003712M37 00000004383M36 00000004912M32 00000004207M37 00000003989M31 00000004669M38 00000004911M34 00000003192M32 00000003711M39 00000004391M39 00000003988M33 00000003101M33 00000003986M37 00000003899M32 00000003916M34 00000003991M37 00000003893M35 00000004385M31 00000003190M36 00000004208M35 00000003716M38 00000003918M30 00000003922M32 00000004577M33 00000004572M34 00000003792M39 00000004392M37 00000004388M35 00000004659M39 00000003407M34 00000004209M33 00000003992M35 00000004575M37 00000004579M39 00000003897M36 00000003913M31 00000004782M39 00000003404M31 00000003915M36 00000004389M33 00000003719M32 00000004660M37 00000004780M33 00000004212M37 00000004384M34 00000003896M38 00000003921M34 00000004386M39 00000003226M38 00000003224M33 00000003412M34 00000003386M30 00000004206M39 00000004215M30 00000003189M38 00000004781M31 00000003892M37 00000003713M35 00000004663M31 00000003715M30 00000003227M36 00000004665M36 00000003409M30 00000004787M38 00000003229M32 00000004416M34 00000003403M33 00000004786M30 00000003191M34 00000004578M31 00000004390M31 00000004785M32 00000003408M32 00000003987M35 00000004661M35 00000003894M33 00000003900M38 00000003383M37 00000004662M33 00000003793M37 00000004664M39 00000004909M38 00000003406M36 00000003901M36 00000003405M38 00000003895M30 00000003710M31 00000003717M36 00000004913M30 00000003898M34 00000004170M37 00000003718M34 00000003411M36 00000003919M38 00000003102M31 00000003225M30 00000003384M35 00000003387M38 00000003794M35 00000003917M32 00000003920M36 00000004213M35 00000004415M36 00000004417M32 00000004581M35 00000004666M34 00000004789M34 00000004916M33 00000004999M39 00000005000M35 00000005063M33 00000005064M31 00001009888WK7 00000003990M39 00000004210M31 00000004214M33 00000003993M33 00000004181M34 00000004414M39 00000004418M30 00000004574M30 00000004667M32 00000004668M30 00000004670M36 00000004784M35 00000004788M36 00000004910M36 00000005001M33 and 00000005070M38. 
Recalling Firm/
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer Reason
for Recall
Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. The collimator stays at the original smaller cassette size and allows the operator to take an exposure.
FDA Determined
Cause 2
Software design
Action Consignees were notified by two "Product Safety Notification" letters on July 10, 2007. Each letter addressed one of the two safety issues with the affected product. The letters provided safety instructions on how avoid the software error and informed users that their representative would contact them to schedule a visit for a software correction installation.
Quantity in Commerce 101
Distribution Worldwide Distribution --USA including states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, ID, IL ,IN, LA, MA, MD, MI, MO,MS, NC, ND, NE, NH, NJ, NM, NV, OH,OK, OR, PA, SC, SD, TN, TX, UT, VA, VT and WA; USA territory of: PR and countries: EGYPT, SAUDI ARABIA, MACEDONIA, FRANCE and GREAT BRITAIN.
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