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Class 2 Device Recall GE Healthcare, Innova |
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Date Initiated by Firm |
March 24, 2010 |
Date Posted |
May 26, 2010 |
Recall Status1 |
Terminated 3 on May 21, 2013 |
Recall Number |
Z-1659-2010 |
Recall Event ID |
55445 |
510(K)Number |
K052412 K052157 K061163
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Product Classification |
Cardiovascular Imaging System - Product Code MQB
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Product |
GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) |
Code Information |
0000009C2M0037 0000009C2M0007 00000008C2M001 0000009C2M0032 0000009C2M0154 0000009C2M0065 0000009C2M0072 0000009C2M0078 0000009C2M0084 0000009C2MOO84 0000009C2M0085 0000009C2M0143 0000009C2M0136 0000009C2M0163 0000009C2M0100 0000009C2M0162 0000009C2M0117 0000009C2M0167 0000009C2M0093 0000009C2M0166 0000009C2M0171 0000009C2M0187 0000009C2M0144 0000009C2M0106 0000009C2M0199 0000009C2M0200 0000010C2M0005 0000009C2M0024 |
Recalling Firm/ Manufacturer |
Ge Healthcare, Llc 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
262-544-3894
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Manufacturer Reason for Recall |
A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios that
will cause the next exam to fail and the inability to recall acquired sequences.
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FDA Determined Cause 2 |
Software design |
Action |
Consignees were sent on 3/24/10, a GE Healthcare " Urgent Medical Device Correction" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information. |
Quantity in Commerce |
28 |
Distribution |
Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS, MOROCCO, REPUBLIC OF KOREA, KAZAKSTAN, JAPAN, ITALY, ISLAMIC REPUBLIC OF IRAN, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ARGENTINA. |
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 = MQB and Original Applicant = GE HEALTHCARE 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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