| Class 2 Device Recall Signa Ovation | |
Date Initiated by Firm | August 23, 2010 |
Date Posted | November 19, 2010 |
Recall Status1 |
Terminated 3 on July 13, 2012 |
Recall Number | Z-0426-2011 |
Recall Event ID |
56380 |
510(K)Number | K002611 K033504 |
Product Classification |
Magnetic resonance diagnostic device - Product Code LNH
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Product | Signa Ovation, 0.35T MR Systems (MFO 1-4).
Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems. |
Code Information |
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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 | If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose. |
Quantity in Commerce | 202 |
Distribution | Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LNH 510(K)s with Product Code = LNH
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