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U.S. Department of Health and Human Services

Class 2 Device Recall LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM

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  Class 2 Device Recall LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM see related information
Date Initiated by Firm February 07, 2012
Date Posted February 23, 2012
Recall Status1 Terminated 3 on July 06, 2012
Recall Number Z-1093-2012
Recall Event ID 60932
510(K)Number K111582  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product GE Healthcare, LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software.

Intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Peripheral Vascular, etc.
Code Information LOGIQ S8 M3 Initial Production with R1.1.1 Software  Serial Number 158236SU0 158237SU8 158240SU2 158241SU0 158242SU8 159132SU0 159133SU8 159134SU6 159135SU3 159253SU4 159254SU2 159255SU9 159256SU7 159257SU5 159769SU9 159770SU7 159771SU5 159772SU3 159773SU1 160126SU9 160127SU7 160128SU5 160129SU3 160130SU1 160527SU8 160528SU6 160529SU4 158804SU5 159790SU5 159791SU3 161696SU0 159240SU1 158246SU9 160530SU2 160531SU0 159245SU0 158259SU2 159250SU0 161693SU7 159243SU5 159776SU4 160385SU1 153254SU8 153255SU5 153256SU3 153257SU1 153258SU9 153259SU7 153260SU5 158243SU6 158244SU4 158245SU1 159241SU9 159242SU7 159596SU6 159597SU4 159598SU2 159599SU0 159600SU6 159601SU4 159602SU2 159603SU0 159605SU5 159606SU3 159607SU1 159608SU9 159947SU1 159948SU9 159949SU7 159950SU5 159951SU3 159952SU1 159953SU9 159954SU7 159955SU4 159956SU2 159957SU0 159958SU8 159959SU6 159960SU4 159961SU2 159962SU0 162830SU4 162831SU2 162832SU0 162833SU8 162834SU6 159244SU3 159248SU4 159251SU8 160740SU7 158759SU1 158766SU6 158767SU4 158805SU2 159249SU2 159774SU9 159775SU6 159777SU2 159778SU0 159779SU8 159781SU4 159785SU5 159786SU3 159793SU9 161694SU5 162596SU1 162597SU9 162598SU7 159782SU2 159783SU0 159784SU8 161687SU9 161688SU7 161689SU5 161690SU3 161691SU1 161692SU9 162593SU8 162594SU6 158760SU9 158761SU7 158762SU5 158763SU3 158764SU1 158765SU8 158799SU7 158800SU3 158801SU1 158802SU9 158803SU7 158806SU0 158807SU8 158808SU6 159247SU6 159780SU6 159787SU1 159788SU9 159789SU7 161695SU2 162592SU0 162595SU3 162599SU5 162600SU1 162601SU9 159246SU8 158768SU2 158247SU7 158248SU5 159604SU8 159766SU5 159767SU3 159768SU1 159963SU8 159964SU6 159965SU3 160741SU5 160742SU3 160743SU1 159252SU6, and  159792SU1.  
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has become aware of a potential safety issue where an image from a different patient, or an image from the current patient with title information from a different patient maybe noticed.
FDA Determined
Cause 2		 Software design
Action Consignees were sent on 2/7/12 a GE Healthcare "Urgent Medical Device Correction" letter dated February 6, 2012. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering and Head of General Imagining Ultrasound Department. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Users were instructed not to press the PRINT key during the specified view in order to avoid seeing the issue. GE will provide a software update at not cost to customers in order to remove the malfunction. Customers are to contact their local GEHC service representative or call 1-800-321-7937 if they have questions or concerns.
Quantity in Commerce 161
Distribution Worldwide Distribution -- US, including the states of NJ, PA, and WI and countries of UNITED KINGDOM, THAILAND, SOUTH KOREA, SLOVENIA, SINGAPORE, ROMANIA, REPUBLIC OF MOLDOVA, POLAND, MALAYSIA, JAPAN, ITALY, INDIA, GERMANY, FRANCE, EUROPE, CZECH REPUBLIC, AUSTRIA, AUSTRALIA, and ARAB EMIRATES.
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 = IYN and Original Applicant = GE HEALTHCARE
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