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U.S. Department of Health and Human Services

Class 2 Device Recall OEC MiniView 6800 Mobile

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 Class 2 Device Recall OEC MiniView 6800 Mobilesee related information
Date Initiated by FirmMarch 27, 2007
Date PostedAugust 01, 2012
Recall Status1 Terminated 3 on August 02, 2012
Recall NumberZ-2126-2012
Recall Event ID 62449
510(K)NumberK992506 
Product Classification System, x-ray, mobile - Product Code IZL
ProductOEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.
Code Information 62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information ContactDeena Pease
801-536-4516
Manufacturer Reason
for Recall
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
FDA Determined
Cause 2
Software design
ActionPlease be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notices dated October 11, 2006 and February 21, 2007 via certified mail delivery letter to affected customers. The notices identified the affected products, problem and actions to be taken. Customers were informed that a GEHC OEC field service engineer would be contacting their facility to arrange to have a replacement hard disk drive installed on the affected system(s). Customers were instructed to ensure that images on the hard disk drive were stored via an alternate permanent media as the hard disk drive approaches the 170 image capacity until a GEHC OEC field service engineer had replaced the drive. For questions regardiug this issues contact the service team at 800-874-7378.
Quantity in CommercePart of a total of 82 units distributed.
DistributionWorldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.
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 = IZL
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